GNT
5 FDA 510(k) clearances · Product code
28 daysmedian time to decision
479 days90th percentile
5clearances measured
FDA profile
- Official device name
- Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3330
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1997: 1 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES (K950838) | Zymetx, Inc. | 1996-06-17 |
| QTEST INFLUENZA A (K913828) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-09-23 |
| DIRECTIGEN FLU A (K902609) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-09-10 |
| INFLUENZA HA ANTIGEN (K780272) | Flow Laboratories, Inc. | 1978-02-28 |
| INFLUENZA HA ANTIGEN A/USSR (K780275) | Flow Laboratories, Inc. | 1978-02-28 |
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Every clearance here is in the API, with alerts when new ones post.