Panels › Microbiology › Product code GNT · Class 1
Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
Regulation 866.3330
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GNT
| Company | 510(k)s | Recalls |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 0 |
| Flow Laboratories, Inc. | 2 | 0 |
| Zymetx, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 17, 1996 | K950838 | VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES Zymetx, Inc. | GNT |
| Sep 23, 1991 | K913828 | QTEST INFLUENZA A Bd Becton Dickinson Vacutainer Systems Preanalytic | GNT |
| Sep 10, 1990 | K902609 | DIRECTIGEN FLU A Bd Becton Dickinson Vacutainer Systems Preanalytic | GNT |
| Feb 28, 1978 | K780275 | INFLUENZA HA ANTIGEN A/USSR Flow Laboratories, Inc. | GNT |
| Feb 28, 1978 | K780272 | INFLUENZA HA ANTIGEN Flow Laboratories, Inc. | GNT |
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