Component Atlas

In-Vitro Diagnostics & Microfluidics

Microfluidic chips, lateral flow membranes, reagent blisters, and optical wells.

19 categories | Component Atlas › In-Vitro Diagnostics & Microfluidics

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19 components

Cartridge & Fluidic Architecture

Microfluidic Consumables
Diagnostic Membranes & Wicks
Reagent Blisters & On-Board Storage
Plasma Separation Membranes
Micro-PCR Thermal Chambers
Fused Silica Optical Flow Cells
Microfluidic Droplet Generator Chips

Reagent Barrier Packaging

Pouches
Cartons & Shippers
Lyophilized Reagent Beads
Pre-Treated Conjugate Release Pads
High-Capacity Absorption Sink Pads
Optically Clear PCR Microplate Seals

Component Catalog & Supplier Offerings

Click any component in the visual grid above to jump to its engineering specifications and listed suppliers below. Click any supplier row for its stated focus, the evidence behind its rating, and one-click RFQ formulation.

Listed from public sources. Not contacted or endorsed by 10xAnd. Evidence ratings count checks against public sources — how they work.

Microfluidic Consumables

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Key Specs: channel width, depth, substrate

Precision molded or laser-bonded COP/glass chips with micro-channels, chambers, and mixers for sample processing.

Supplier	Stated Capabilities & Technical Focus	Procurement
SCHOTT MINIFAB Scoresby, Australia / Jena, Germany	Custom polymer (COC/COP, PMMA) and glass microfluidic consumables, laser bonding ISO 13485 stated on site FDA registered · FEI 3017983854	RFQ ›
Microfluidic Consumables SCHOTT MINIFAB — Microfluidic Consumables Engineering Profile Custom polymer (COC/COP, PMMA) and glass microfluidic consumables, laser bonding Key Specs: channel width, depth, substrate Facility: Scoresby, Australia / Jena, Germany Visit SCHOTT MINIFAB website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “reusable and single-use medtech devices, SCHOTT offers” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: microfluidic · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “are certified to ISO 9001:2015, ISO 13485:2016, ISO” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as SCHOTT MINIFAB PTY LTD: FEI 3017983854; Contract Manufacturer; Scoresby Victoria, AU · FDA record ↗ · checked 2026-10-20
Carclo Technical Plastics carclo-ctp.co.uk Website did not answer as this company on 2026-10-20 Mitcham, UK	Precision injection molding of micro-feature cartridges with sub-micron channel fidelity	RFQ ›
Microfluidic Consumables Carclo Technical Plastics — Microfluidic Consumables Engineering Profile Precision injection molding of micro-feature cartridges with sub-micron channel fidelity Key Specs: channel width, depth, substrate Facility: Mitcham, UK carclo-ctp.co.uk Website did not answer as this company on 2026-10-20 DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — no answer The listed website did not return this company’s own page on the check date. (TLS error (ERR_TLS_CERT_ALTNAME_INVALID)) carclo-ctp.co.uk, not linked · checked 2026-10-20 Site says it serves medical devices — not checked site not read (TLS error (ERR_TLS_CERT_ALTNAME_INVALID)). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (TLS error (ERR_TLS_CERT_ALTNAME_INVALID)). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (TLS error (ERR_TLS_CERT_ALTNAME_INVALID)). Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: GB. what was checked ↗ · checked 2026-10-20
Micronit Microtechnologies Enschede, Netherlands	Glass, silicon, and hybrid microfluidic chips, micro-channels, droplet generators	RFQ ›
Microfluidic Consumables Micronit Microtechnologies — Microfluidic Consumables Engineering Profile Glass, silicon, and hybrid microfluidic chips, micro-channels, droplet generators Key Specs: channel width, depth, substrate Facility: Enschede, Netherlands Visit Micronit Microtechnologies website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — not checked blocked automated access (HTTP 429). Could not be checked, so it counts neither way. Site says it serves medical devices — not checked site not read (blocked automated access (HTTP 429)). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (blocked automated access (HTTP 429)). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (blocked automated access (HTTP 429)). Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: NL. what was checked ↗ · checked 2026-10-20

Diagnostic Membranes & Wicks

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Key Specs: capillary flow rate, bed volume

Nitrocellulose capillary membranes and treated porous pads governing sample flow in lateral flow immunoassays.

Supplier	Stated Capabilities & Technical Focus	Procurement
MilliporeSigma (Merck KGaA) Burlington, MA, USA / Darmstadt, Germany	Hi-Flow membrane rolls, treated sample wicking pads for lateral flow immunoassays FDA registered · FEI 3002806906	RFQ ›
Diagnostic Membranes & Wicks MilliporeSigma (Merck KGaA) — Diagnostic Membranes & Wicks Engineering Profile Hi-Flow membrane rolls, treated sample wicking pads for lateral flow immunoassays Key Specs: capillary flow rate, bed volume Facility: Burlington, MA, USA / Darmstadt, Germany Visit MilliporeSigma (Merck KGaA) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — not checked timeout after 12 s. Could not be checked, so it counts neither way. Site says it serves medical devices — not checked site not read (timeout after 12 s). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (timeout after 12 s). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (timeout after 12 s). Could not be checked, so it counts neither way. FDA establishment registration — found Registered as MERCK KGAA: FEI 3002806906; Manufacturer, Contract Manufacturer; Darmstadt Hesse, DE · FDA record ↗ · checked 2026-10-20
Sartorius Stedim Biotech Goettingen, Germany	UniSart nitrocellulose membranes with uniform capillary flow time and low background	RFQ ›
Diagnostic Membranes & Wicks Sartorius Stedim Biotech — Diagnostic Membranes & Wicks Engineering Profile UniSart nitrocellulose membranes with uniform capillary flow time and low background Key Specs: capillary flow rate, bed volume Facility: Goettingen, Germany Visit Sartorius Stedim Biotech website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — not found No statement that it serves medical devices or medical device makers was found on the pages read. (no medical-market phrase in page body on 9 pages read) what was checked ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: membranes · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 9 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: DE. what was checked ↗ · checked 2026-10-20
Cytiva (Whatman) Amersham, UK / Marlborough, MA, USA	Hi-Flow Plus nitrocellulose, glass fiber conjugate pads, and cellulose sample wicks	RFQ ›
Diagnostic Membranes & Wicks Cytiva (Whatman) — Diagnostic Membranes & Wicks Engineering Profile Hi-Flow Plus nitrocellulose, glass fiber conjugate pads, and cellulose sample wicks Key Specs: capillary flow rate, bed volume Facility: Amersham, UK / Marlborough, MA, USA Visit Cytiva (Whatman) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — not checked network error (UND_ERR_HEADERS_OVERFLOW). Could not be checked, so it counts neither way. Site says it serves medical devices — not checked site not read (network error (UND_ERR_HEADERS_OVERFLOW)). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (network error (UND_ERR_HEADERS_OVERFLOW)). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (network error (UND_ERR_HEADERS_OVERFLOW)). Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: MA, GB. what was checked ↗ · checked 2026-10-20

Reagent Blisters & On-Board Storage

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Key Specs: burst pressure, moisture vapor, volume

Hermetic foil blister pouches with calibrated burst seals releasing liquid reagents upon cartridge insertion.

Supplier	Stated Capabilities & Technical Focus	Procurement
Bio-Rad Laboratories OEM Hercules, CA, USA	Lyophilized reagent beads, room-temperature stable enzyme packaging FDA registered · FEI 3010127294	RFQ ›
Reagent Blisters & On-Board Storage Bio-Rad Laboratories OEM — Reagent Blisters & On-Board Storage Engineering Profile Lyophilized reagent beads, room-temperature stable enzyme packaging Key Specs: burst pressure, moisture vapor, volume Facility: Hercules, CA, USA Visit Bio-Rad Laboratories OEM website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “therapeutics, developing revolutionary medical devices, or transforming” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: reagent, storage · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — found Registered as Bio-Rad Laboratories Inc.: FEI 3010127294; Manufacturer, Specification Developer, Contract Manufacturer; Irvine, CA · FDA record ↗ · checked 2026-10-20
J-Pac Medical Somersworth, NH, USA	Liquid blister pouches with burst-seal release, micro-volume reagent encapsulation	RFQ ›
Reagent Blisters & On-Board Storage J-Pac Medical — Reagent Blisters & On-Board Storage Engineering Profile Liquid blister pouches with burst-seal release, micro-volume reagent encapsulation Key Specs: burst pressure, moisture vapor, volume Facility: Somersworth, NH, USA Visit J-Pac Medical website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “cleanroom facility — FDA-registered medical device manufacturing” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: reagent, packaging · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not checked group statement does not name the company. Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: NH. what was checked ↗ · checked 2026-10-20
Aptar CSP Technologies Auburn, AL, USA	Active desiccant vials, moisture-scavenging foil packaging for diagnostic strips	RFQ ›
Reagent Blisters & On-Board Storage Aptar CSP Technologies — Reagent Blisters & On-Board Storage Engineering Profile Active desiccant vials, moisture-scavenging foil packaging for diagnostic strips Key Specs: burst pressure, moisture vapor, volume Facility: Auburn, AL, USA Visit Aptar CSP Technologies website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — not found No statement that it serves medical devices or medical device makers was found on the pages read. (no medical-market phrase in page body on 10 pages read) what was checked ↗ · checked 2026-10-20 Site names this capability — not found information only, not scored This category’s capability terms were not all found on the pages read. Looked for: “reagent…” and (“blister…” or “storage” or “packag…” or “pack…”). Found: packaging. what was checked ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: IL, FR. what was checked ↗ · checked 2026-10-20

Plasma Separation Membranes

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Key Specs: whole blood separation, low hemolysis, recovery

Asymmetric porous polysulfone and glass-fiber matrix membranes that separate red blood cells from plasma without centrifugation.

Supplier	Stated Capabilities & Technical Focus	Procurement
Porex Corporation Fairburn, GA, USA	Porous polymer and glass fiber matrices for whole blood separation ISO 13485 stated on site FDA registered · FEI 1043678	RFQ ›
Plasma Separation Membranes Porex Corporation — Plasma Separation Membranes Engineering Profile Porous polymer and glass fiber matrices for whole blood separation Key Specs: whole blood separation, low hemolysis, recovery Facility: Fairburn, GA, USA Visit Porex Corporation website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “industries––including manufacturers of medical devices, diagnostics, consumer” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: filters · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 13485:2016” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as POREX CORPORATION: FEI 1043678; Manufacturer; Fairburn, GA · FDA record ↗ · checked 2026-10-20
MilliporeSigma Burlington, MA, USA	Hi-Flow Plus nitrocellulose and asymmetric filtration membranes	RFQ ›
Plasma Separation Membranes MilliporeSigma — Plasma Separation Membranes Engineering Profile Hi-Flow Plus nitrocellulose and asymmetric filtration membranes Key Specs: whole blood separation, low hemolysis, recovery Facility: Burlington, MA, USA Visit MilliporeSigma website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — not checked timeout after 12 s. Could not be checked, so it counts neither way. Site says it serves medical devices — not checked site not read (timeout after 12 s). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (timeout after 12 s). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (timeout after 12 s). Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: MA. what was checked ↗ · checked 2026-10-20
Pall Medical (Cytiva) Port Washington, NY, USA	Vivid plasma separation membranes with low non-specific protein binding	RFQ ›
Plasma Separation Membranes Pall Medical (Cytiva) — Plasma Separation Membranes Engineering Profile Vivid plasma separation membranes with low non-specific protein binding Key Specs: whole blood separation, low hemolysis, recovery Facility: Port Washington, NY, USA Visit Pall Medical (Cytiva) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — not checked network error (UND_ERR_HEADERS_OVERFLOW). Could not be checked, so it counts neither way. Site says it serves medical devices — not checked site not read (network error (UND_ERR_HEADERS_OVERFLOW)). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (network error (UND_ERR_HEADERS_OVERFLOW)). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (network error (UND_ERR_HEADERS_OVERFLOW)). Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: MA, GB. what was checked ↗ · checked 2026-10-20

Micro-PCR Thermal Chambers

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Key Specs: thin-wall COC, thermal transfer, optical clear

Cyclic olefin copolymer (COC) micro-wells with ultra-thin floor walls designed for rapid 30-cycle thermal cycling and fluorescent readout.

Supplier	Stated Capabilities & Technical Focus	Procurement
MiniFAB (Schott Minifab) Scoresby, Australia / Southbridge, MA, USA	Custom polymer microfluidic cartridges with rapid thermal transfer wells ISO 13485 stated on site FDA registered · FEI 3017983854	RFQ ›
Micro-PCR Thermal Chambers MiniFAB (Schott Minifab) — Micro-PCR Thermal Chambers Engineering Profile Custom polymer microfluidic cartridges with rapid thermal transfer wells Key Specs: thin-wall COC, thermal transfer, optical clear Facility: Scoresby, Australia / Southbridge, MA, USA Visit MiniFAB (Schott Minifab) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “Specializing in in vitro diagnostics and life” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: microfluidic · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “are certified to ISO 9001:2015, ISO 13485:2016, ISO” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as SCHOTT MINIFAB PTY LTD: FEI 3017983854; Contract Manufacturer; Scoresby Victoria, AU · FDA record ↗ · checked 2026-10-20
Phillips-Medisize Hudson, WI, USA	Precision molding of ultra-thin-walled disposable diagnostic micro-wells ISO 13485 stated on site FDA registered · FEI 3004058281	RFQ ›
Micro-PCR Thermal Chambers Phillips-Medisize — Micro-PCR Thermal Chambers Engineering Profile Precision molding of ultra-thin-walled disposable diagnostic micro-wells Key Specs: thin-wall COC, thermal transfer, optical clear Facility: Hudson, WI, USA Visit Phillips-Medisize website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “world’s leading pharmaceutical, medtech and in vitro” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: pcr · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “Quality Management System (QMS) certified to ISO 13485.” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as PHILLIPS-MEDISIZE, LLC: FEI 3004058281; Contract Manufacturer; New Richmond, WI · FDA record ↗ · checked 2026-10-20
Microfluidic ChipShop Jena, Germany	Thin-wall cyclic olefin copolymer (COC) optical PCR reaction chambers ISO 13485 stated on site FDA registered · FEI 3009503618	RFQ ›
Micro-PCR Thermal Chambers Microfluidic ChipShop — Micro-PCR Thermal Chambers Engineering Profile Thin-wall cyclic olefin copolymer (COC) optical PCR reaction chambers Key Specs: thin-wall COC, thermal transfer, optical clear Facility: Jena, Germany Visit Microfluidic ChipShop website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — not found No statement that it serves medical devices or medical device makers was found on the pages read. (no medical-market phrase in page body on 10 pages read) what was checked ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: pcr · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 9001 & 13485 certified.” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as MICROFLUIDIC CHIPSHOP GMBH: FEI 3009503618; Manufacturer, Contract Manufacturer; Jena Thuringia, DE · FDA record ↗ · checked 2026-10-20

Fused Silica Optical Flow Cells

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Key Specs: hydrodynamic focusing channel, quartz window, UV trans

Optically clear microfabricated quartz or borosilicate flow channels guiding single-file cell suspensions through laser interrogation zones in flow cytometers.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Microfluidic Droplet Generator Chips

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Key Specs: fluorophilic micro-junction, 20–50µm nozzle, oil emulsion

COC or PDMS micro-junction chips generating uniform picoliter water-in-oil droplets at kilohertz frequencies for digital PCR and single-cell RNA sequencing.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Seals & O-Rings

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Key Specs: ID, wall, material

Elastomeric seals. ID versus OD versus wall is the classic ordering mistake, which is why they carry glyphs.

Supplier	Stated Capabilities & Technical Focus	Procurement
Apple Rubber Products Lancaster, NY, USA	Microminiature O-rings in medical-grade silicone, FKM, EPDM	RFQ ›
Seals & O-Rings Apple Rubber Products — Seals & O-Rings Engineering Profile Microminiature O-rings in medical-grade silicone, FKM, EPDM Key Specs: ID, wall, material Facility: Lancaster, NY, USA Visit Apple Rubber Products website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “Safety: Ensures that medical devices function as” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: seal · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: NY. what was checked ↗ · checked 2026-10-20
Bal Seal Engineering Foothill Ranch, CA, USA	Spring-energized PTFE seals for low friction, sterilizable fluid handles	RFQ ›
Seals & O-Rings Bal Seal Engineering — Seals & O-Rings Engineering Profile Spring-energized PTFE seals for low friction, sterilizable fluid handles Key Specs: ID, wall, material Facility: Foothill Ranch, CA, USA Visit Bal Seal Engineering website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “protects millions of medical devices and critical” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: seal · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: CA. what was checked ↗ · checked 2026-10-20
Trelleborg Sealing Solutions Fort Wayne, IN, USA / Stuttgart, Germany	Liquid silicone rubber (LSR) injection molded seals and Class VI O-rings	RFQ ›
Seals & O-Rings Trelleborg Sealing Solutions — Seals & O-Rings Engineering Profile Liquid silicone rubber (LSR) injection molded seals and Class VI O-rings Key Specs: ID, wall, material Facility: Fort Wayne, IN, USA / Stuttgart, Germany Visit Trelleborg Sealing Solutions website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “solutions for demanding medical device, biotech and” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: seals · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 11 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: IN, DE. what was checked ↗ · checked 2026-10-20

Luer Fittings

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Key Specs: ISO 80369-7, sex

Male and female luer connectors for fluid paths, specified by ISO 80369-7.

📐 Standard Stock Sizes & Scales

Standard ISO 80369-7 Luer Lock Connectors & Barbed Adaptors

ISO 80369-7:2021 (Intravascular or Hypodermic Luer Applications)

Select Configuration & Tubing Barb:

Draft RFQ for Selected Size ›

Type: Male Lock Barb ID: 0.0625″ (1.6 mm) Material: Radiation-stable PP / PC Target: Infusion pump tubing, micro-bore lines

Toggle Complete Stock Size Table (8 sizes)

Configuration	Type	Barb ID (in)	Barb (mm)	Material	Application	Action
Male Luer Lock to 1/16″ (1.6 mm) Barb	Male Lock	0.0625″	1.6	Radiation-stable PP / PC	Infusion pump tubing, micro-bore lines	RFQ ›
Male Luer Lock to 3/32″ (2.4 mm) Barb	Male Lock	0.0938″	2.4	Polycarbonate (USP Class VI)	Standard IV line extension, syringe pump	RFQ ›
Male Luer Lock to 1/8″ (3.2 mm) Barb	Male Lock	0.1250″	3.2	Polycarbonate / Kynar	Manifold fluid delivery, pressure monitoring	RFQ ›
Male Luer Lock to 5/32″ (4.0 mm) Barb	Male Lock	0.1563″	4.0	Polycarbonate	High-flow fluid irrigation & drainage lines	RFQ ›
Female Luer Lock to 1/16″ (1.6 mm) Barb	Female Lock	0.0625″	1.6	Polypropylene / PC	Catheter proximal hub interface	RFQ ›
Female Luer Lock to 3/32″ (2.4 mm) Barb	Female Lock	0.0938″	2.4	Polypropylene / PC	Standard venous access hub	RFQ ›
Female Luer Lock to 1/8″ (3.2 mm) Barb	Female Lock	0.1250″	3.2	Polycarbonate	Multi-lumen catheter junction	RFQ ›
Female Luer to 1/4-28 UNF Flat-Bottom Thread	Female to Thread	1/4-28 UNF	—	316L Stainless / PEEK	High-pressure chromatography & HPLC fluidics	RFQ ›

Supplier	Stated Capabilities & Technical Focus	Procurement
Nordson Medical Fort Collins, CO, USA	Precision molded luers, tube-to-luer barb connectors with zero flash ISO 13485 stated on site	RFQ ›
Luer Fittings Nordson Medical — Luer Fittings Engineering Profile Precision molded luers, tube-to-luer barb connectors with zero flash Key Specs: ISO 80369-7, sex Facility: Fort Collins, CO, USA Visit Nordson Medical website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “Delivering advanced cardiovascular surgical devices—including myocardial protection” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: luers · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 13485 and 14971 Risk Management certified” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: MN. what was checked ↗ · checked 2026-10-20
Qosina Ronkonkoma, NY, USA	Vast inventory of ISO 80369-7 compliant male and female luers in lipid-resistant PC ISO 13485 stated on site	RFQ ›
Luer Fittings Qosina — Luer Fittings Engineering Profile Vast inventory of ISO 80369-7 compliant male and female luers in lipid-resistant PC Key Specs: ISO 80369-7, sex Facility: Ronkonkoma, NY, USA Visit Qosina website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “You to the Medical Components You Need” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: luer · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 13485” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: NY. what was checked ↗ · checked 2026-10-20
Ark-Plas Products ark-plas.com Website did not answer as this company on 2026-10-20 Flippin, AR, USA	Miniature plastic fittings, check valves, and luer lock adapters	RFQ ›
Luer Fittings Ark-Plas Products — Luer Fittings Engineering Profile Miniature plastic fittings, check valves, and luer lock adapters Key Specs: ISO 80369-7, sex Facility: Flippin, AR, USA ark-plas.com Website did not answer as this company on 2026-10-20 DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — no answer The listed website did not return this company’s own page on the check date. (TLS certificate expired) ark-plas.com, not linked · checked 2026-10-20 Site says it serves medical devices — not checked site not read (TLS certificate expired). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (TLS certificate expired). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (TLS certificate expired). Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: AR. what was checked ↗ · checked 2026-10-20

Disposable Microfluidic Pumps

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Key Specs: bidirectional, dead volume, pressure head

Miniature piezo-driven diaphragm pumps integrated into disposable point-of-care cartridges to drive fluidic sample protocols.

Supplier	Stated Capabilities & Technical Focus	Procurement
KNF Neuberger Trenton, NJ, USA	Micro-diaphragm liquid and gas pumps for IVD diagnostic instruments	RFQ ›
Disposable Microfluidic Pumps KNF Neuberger — Disposable Microfluidic Pumps Engineering Profile Micro-diaphragm liquid and gas pumps for IVD diagnostic instruments Key Specs: bidirectional, dead volume, pressure head Facility: Trenton, NJ, USA Visit KNF Neuberger website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “the use in medical technology, laboratory analysis,” · source ↗ · checked 2026-10-20 Site names this capability — not found information only, not scored This category’s capability terms were not all found on the pages read. Looked for: “piezo…” and “pump…”. Found: pumps. what was checked ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: NJ. what was checked ↗ · checked 2026-10-20
Takasago Fluidic Systems Nagoya, Japan / Westborough, MA, USA	Miniature piezoelectric check-valve diaphragm pumps for microfluidic chips	RFQ ›
Disposable Microfluidic Pumps Takasago Fluidic Systems — Disposable Microfluidic Pumps Engineering Profile Miniature piezoelectric check-valve diaphragm pumps for microfluidic chips Key Specs: bidirectional, dead volume, pressure head Facility: Nagoya, Japan / Westborough, MA, USA Visit Takasago Fluidic Systems website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “Fluidic Unit for an IVD instrument” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: piezoelectric, pumps · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: MA, JP. what was checked ↗ · checked 2026-10-20
Parker Hannifin (Precision Fluidics) Hollis, NH, USA	Ultra-compact piezo and solenoid pumps for microfluidic cassettes	RFQ ›
Disposable Microfluidic Pumps Parker Hannifin (Precision Fluidics) — Disposable Microfluidic Pumps Engineering Profile Ultra-compact piezo and solenoid pumps for microfluidic cassettes Key Specs: bidirectional, dead volume, pressure head Facility: Hollis, NH, USA Visit Parker Hannifin (Precision Fluidics) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — not checked blocked automated access (HTTP 403). Could not be checked, so it counts neither way. Site says it serves medical devices — not checked site not read (blocked automated access (HTTP 403)). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (blocked automated access (HTTP 403)). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (blocked automated access (HTTP 403)). Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: NH. what was checked ↗ · checked 2026-10-20

Elastomeric Micro Duckbill Valves

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Key Specs: low crack pressure (0.2 psi), liquid silicone, anti-backflow

One-piece elastomeric silicone or fluorosilicone slit check valves that permit forward reagent flow while preventing reverse contamination in microfluidic cartridges.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Rare-Earth Magnet Separation Arrays

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Key Specs: NdFeB N52, high gradient magnetic field, 96-well format

Precision arrays of neodymium-iron-boron permanent magnets designed to rapidly pull paramagnetically labeled DNA/RNA beads to well walls during automated wash steps.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Screen-Printed Biosensor Electrodes

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Key Specs: carbon/Ag/AgCl inks, enzyme immobilization, 3-electrode

Planar polymer substrates screen-printed with working, counter, and reference electrodes coated with glucose oxidase or dehydrogenase for amperometric biosensing.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Pouches

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Key Specs: seal, film, peel

Header bags and formed pouches — usually a film laminate sealed to a porous web that lets sterilant in and keeps organisms out. The seal is the barrier, not the film.

Supplier	Stated Capabilities & Technical Focus	Procurement
Amcor Flexibles Healthcare Mundelein, IL, USA / Zurich, Switzerland	High-barrier coextruded films, peelable sterilizable medical pouches ISO 13485 stated on site FDA registered · FEI 3003243311	RFQ ›
Pouches Amcor Flexibles Healthcare — Pouches Engineering Profile High-barrier coextruded films, peelable sterilizable medical pouches Key Specs: seal, film, peel Facility: Mundelein, IL, USA / Zurich, Switzerland Visit Amcor Flexibles Healthcare website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “New recycle-ready, high-barrier laminates for medical devices” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: pouches · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “Amcor Winterbourne achieves ISO 13485:2016 certification, strengthening its” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as AMCOR FLEXIBLES, LLC: FEI 3003243311; Contract Manufacturer, Manufacturer; Mundelein, IL · FDA record ↗ · checked 2026-10-20
Oliver Healthcare Packaging Grand Rapids, MI, USA / Venray, Netherlands	Tyvek/film chevron pouches, breathable header bags compliant with ISO 11607 ISO 13485 stated on site	RFQ ›
Pouches Oliver Healthcare Packaging — Pouches Engineering Profile Tyvek/film chevron pouches, breathable header bags compliant with ISO 11607 Key Specs: seal, film, peel Facility: Grand Rapids, MI, USA / Venray, Netherlands Visit Oliver Healthcare Packaging website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “Application of Risk Management to Medical Devices” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: pouches · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 13485:2016” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: MI. what was checked ↗ · checked 2026-10-20
SteriPack Medical Clara, Ireland / Lakeland, FL, USA	Cleanroom pouch converting, foil moisture-barrier pouches, contract packaging	RFQ ›
Pouches SteriPack Medical — Pouches Engineering Profile Cleanroom pouch converting, foil moisture-barrier pouches, contract packaging Key Specs: seal, film, peel Facility: Clara, Ireland / Lakeland, FL, USA Visit SteriPack Medical website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — not checked TLS chain not verifiable by our client (UNABLE_TO_VERIFY_LEAF_SIGNATURE). Could not be checked, so it counts neither way. Site says it serves medical devices — not checked site not read (TLS chain not verifiable by our client (UNABLE_TO_VERIFY_LEAF_SIGNATURE)). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (TLS chain not verifiable by our client (UNABLE_TO_VERIFY_LEAF_SIGNATURE)). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (TLS chain not verifiable by our client (UNABLE_TO_VERIFY_LEAF_SIGNATURE)). Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: FL, IE. what was checked ↗ · checked 2026-10-20

Cartons & Shippers

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Key Specs: protection, distribution

Shelf cartons and distribution packaging. Protective rather than sterile-barrier: it defends the barrier through distribution, and is qualified against that job.

Supplier	Stated Capabilities & Technical Focus	Procurement
Sonoco Healthcare Hartsville, SC, USA	Temperature-assured insulated shippers and protective chipboard cartons ISO 13485 stated on site	RFQ ›
Cartons & Shippers Sonoco Healthcare — Cartons & Shippers Engineering Profile Temperature-assured insulated shippers and protective chipboard cartons Key Specs: protection, distribution Facility: Hartsville, SC, USA Visit Sonoco Healthcare website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “support the manufacturing of your medical device.” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: corrugated · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 13485” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: SC. what was checked ↗ · checked 2026-10-20
Smurfit Westrock Atlanta, GA, USA	Distribution corrugated packaging, humidity-resistant folding medical cartons	RFQ ›
Cartons & Shippers Smurfit Westrock — Cartons & Shippers Engineering Profile Distribution corrugated packaging, humidity-resistant folding medical cartons Key Specs: protection, distribution Facility: Atlanta, GA, USA Visit Smurfit Westrock website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “medical device packaging” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: carton · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: GA. what was checked ↗ · checked 2026-10-20
Great Northern Corporation Appleton, WI, USA	ISTA-certified ISTA 2A/3A validated corrugated shippers and drop-test packaging	RFQ ›
Cartons & Shippers Great Northern Corporation — Cartons & Shippers Engineering Profile ISTA-certified ISTA 2A/3A validated corrugated shippers and drop-test packaging Key Specs: protection, distribution Facility: Appleton, WI, USA Visit Great Northern Corporation website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — not found No statement that it serves medical devices or medical device makers was found on the pages read. (no medical-market phrase in page body on 9 pages read) what was checked ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: carton · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 9 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: WI. what was checked ↗ · checked 2026-10-20

Lyophilized Reagent Beads

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Key Specs: single-dose sphere, ambient stable, PCR mastermix

Pre-metered freeze-dried enzyme and primer microspheres packaged inside disposable diagnostic cartridges for ambient shipping.

Supplier	Stated Capabilities & Technical Focus	Procurement
Biofortuna Deeside, UK	Custom freeze-dried unit-dose PCR reagent spheres for cartridge integration ISO 13485 stated on site	RFQ ›
Lyophilized Reagent Beads Biofortuna — Lyophilized Reagent Beads Engineering Profile Custom freeze-dried unit-dose PCR reagent spheres for cartridge integration Key Specs: single-dose sphere, ambient stable, PCR mastermix Facility: Deeside, UK Visit Biofortuna website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “experience of an IVD product, enhancing your” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: lyophilisation · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “is ISO 13485 and ISO 17025 accredited, FDA” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: GB. what was checked ↗ · checked 2026-10-20
Qiagen OEM Hilden, Germany / Germantown, MD, USA	Pre-dispensed ambient-stable lyophilized master mixes and enzymes FDA registered · FEI 3004013603	RFQ ›
Lyophilized Reagent Beads Qiagen OEM — Lyophilized Reagent Beads Engineering Profile Pre-dispensed ambient-stable lyophilized master mixes and enzymes Key Specs: single-dose sphere, ambient stable, PCR mastermix Facility: Hilden, Germany / Germantown, MD, USA Visit Qiagen OEM website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “generation of automated IVD nucleic acid extraction.” · source ↗ · checked 2026-10-20 Site names this capability — not found information only, not scored This category’s capability terms were not all found on the pages read. Looked for: “lyophili…” or “freeze-dr…” or “freeze dr…”. what was checked ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — found Registered as QIAGEN, GMBH: FEI 3004013603; Specification Developer, Manufacturer, Contract Manufacturer; Hilden North Rhine-Westphalia, DE · FDA record ↗ · checked 2026-10-20
Lyophilization Technology, Inc. lyotech.com Website did not answer as this company on 2026-10-20 Warminster, PA, USA	Contract lyophilization of single-dose molecular diagnostic beads	RFQ ›
Lyophilized Reagent Beads Lyophilization Technology, Inc. — Lyophilized Reagent Beads Engineering Profile Contract lyophilization of single-dose molecular diagnostic beads Key Specs: single-dose sphere, ambient stable, PCR mastermix Facility: Warminster, PA, USA lyotech.com Website did not answer as this company on 2026-10-20 DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — no answer The listed website did not return this company’s own page on the check date. (HTTP 200, but no page read names Lyophilization Technology, Inc. (domain may have changed hands)) lyotech.com, not linked · checked 2026-10-20 Site says it serves medical devices — not checked no page read names the company, so its statements are not this company’s. Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored no page read names the company, so its statements are not this company’s. Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked no page read names the company, so its statements are not this company’s. Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: PA. what was checked ↗ · checked 2026-10-20

Pre-Treated Conjugate Release Pads

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Key Specs: glass fiber web, gold nanoshell release, sucrose blocker

Surface-blocked glass fiber and polyester nonwoven matrices carrying dried colloidal gold or fluorescent reporter antibody conjugates for lateral flow assays.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

High-Capacity Absorption Sink Pads

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Key Specs: cotton linter cellulose, 30–50 sec/4cm wicking rate

High-density cotton cellulose filter papers placed at the distal end of immunochromatographic strips to drive capillary sample pull across detection lines.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Optically Clear PCR Microplate Seals

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Key Specs: polyolefin pressure adhesive, zero autofluorescence, -40°C to 110°C

Non-tacky pressure-activated adhesive polyolefin films sealing 96-well and 384-well PCR plates against evaporation through 40 thermal cycles without interfering with qPCR optics.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Cartridge & Fluidic Architecture

Fluid Control & Sealing

Reagent Barrier Packaging

Component Catalog & Supplier Offerings

SCHOTT MINIFAB — Microfluidic Consumables Engineering Profile

Carclo Technical Plastics — Microfluidic Consumables Engineering Profile

Micronit Microtechnologies — Microfluidic Consumables Engineering Profile

MilliporeSigma (Merck KGaA) — Diagnostic Membranes & Wicks Engineering Profile

Sartorius Stedim Biotech — Diagnostic Membranes & Wicks Engineering Profile

Cytiva (Whatman) — Diagnostic Membranes & Wicks Engineering Profile

Bio-Rad Laboratories OEM — Reagent Blisters & On-Board Storage Engineering Profile

J-Pac Medical — Reagent Blisters & On-Board Storage Engineering Profile

Aptar CSP Technologies — Reagent Blisters & On-Board Storage Engineering Profile

Porex Corporation — Plasma Separation Membranes Engineering Profile

MilliporeSigma — Plasma Separation Membranes Engineering Profile

Pall Medical (Cytiva) — Plasma Separation Membranes Engineering Profile

MiniFAB (Schott Minifab) — Micro-PCR Thermal Chambers Engineering Profile

Phillips-Medisize — Micro-PCR Thermal Chambers Engineering Profile

Microfluidic ChipShop — Micro-PCR Thermal Chambers Engineering Profile

Apple Rubber Products — Seals & O-Rings Engineering Profile

Bal Seal Engineering — Seals & O-Rings Engineering Profile

Trelleborg Sealing Solutions — Seals & O-Rings Engineering Profile

Standard ISO 80369-7 Luer Lock Connectors & Barbed Adaptors

Nordson Medical — Luer Fittings Engineering Profile

Qosina — Luer Fittings Engineering Profile

Ark-Plas Products — Luer Fittings Engineering Profile

KNF Neuberger — Disposable Microfluidic Pumps Engineering Profile

Takasago Fluidic Systems — Disposable Microfluidic Pumps Engineering Profile

Parker Hannifin (Precision Fluidics) — Disposable Microfluidic Pumps Engineering Profile

Amcor Flexibles Healthcare — Pouches Engineering Profile

Oliver Healthcare Packaging — Pouches Engineering Profile

SteriPack Medical — Pouches Engineering Profile

Sonoco Healthcare — Cartons & Shippers Engineering Profile

Smurfit Westrock — Cartons & Shippers Engineering Profile

Great Northern Corporation — Cartons & Shippers Engineering Profile

Biofortuna — Lyophilized Reagent Beads Engineering Profile

Qiagen OEM — Lyophilized Reagent Beads Engineering Profile

Lyophilization Technology, Inc. — Lyophilized Reagent Beads Engineering Profile