GNT — Antigens, Ha (Including Ha Control), Influenza Virus A, B, C Class I
FDA product code GNT covers "Antigens, Ha (Including Ha Control), Influenza Virus A, B, C", a Class I medical device regulated under 21 CFR 866.3330. Submissions are reviewed by the Microbiology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GNT
- Device Class
- Class I
- Regulation Number
- 866.3330
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950838 | zymetx | VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES | June 17, 1996 |
| K913828 | bd becton dickinson vacutainer systems preanalytic | QTEST INFLUENZA A | September 23, 1991 |
| K902609 | bd becton dickinson vacutainer systems preanalytic | DIRECTIGEN FLU A | September 10, 1990 |
| K780275 | flow laboratories | INFLUENZA HA ANTIGEN A/USSR | February 28, 1978 |
| K780272 | flow laboratories | INFLUENZA HA ANTIGEN | February 28, 1978 |