FDA product code · Microbiology · Class 2
OZE: Influenza A And Influenza B Multiplex Nucleic Acid Assay
OZE is FDA's product code for "Influenza A And Influenza B Multiplex Nucleic Acid Assay": a Class 2 device classified under 21 CFR 866.3980, reviewed by the Microbiology panel.
510(k) review time for OZE
Across 11 510(k) clearances under OZE decided from 2018-01-01 to 2026-10-06, the median was 43 days from FDA receipt to decision. Half took between 31 and 160 days, and 80% were decided within 222 days. These are past clearances, not a forecast for a new submission.
| Fastest | 25 |
|---|---|
| 25th percentile | 31 |
| Median | 43 |
| 75th percentile | 160 |
| 80th percentile | 222 |
| 90th percentile | 249 |
| Slowest | 268 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FDA-recognized standards that cite OZE
No FDA recognized consensus standard cites OZE by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.
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