Antisera, Hai, Influenza Virus A, B, C
The Influenza Virus A, B, and C HAI (Hemagglutination Inhibition) Antisera are serological reagents used in hemagglutination inhibition tests to identify and subtype influenza virus strains, a standard approach used in virology laboratories and influenza surveillance programs. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GNS, regulated under 21 CFR 866.3330 in the Microbiology specialty.
Research product code GNS in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- GNS
- Device Class
- FDA class 1
- Regulation Number
- 866.3330
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K780697 | GOAT ANTI-INFLUENZA ANTISERA ATEXAS | May 03, 1978 | Substantially Equivalent | Northeast Biomedical Labs., Inc. |
| K780696 | GOAT ANTIINFLUENZA ANTISERA AUSSR | May 03, 1978 | Substantially Equivalent | Northeast Biomedical Labs., Inc. |
| K780277 | INFLUENZA HI PRESERUM A/TEXAS | Feb 28, 1978 | Substantially Equivalent | Flow Laboratories, Inc. |
| K780276 | INFLUENZA HI ANTISERUM A/TEXAS | Feb 28, 1978 | Substantially Equivalent | Flow Laboratories, Inc. |
| K780274 | INFLUENZA HI ANTISERUM | Feb 28, 1978 | Substantially Equivalent | Flow Laboratories, Inc. |
| K780273 | INFLUENZA HI PRESERUM | Feb 28, 1978 | Substantially Equivalent | Flow Laboratories, Inc. |
| K780006 | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 | Substantially Equivalent | Northeast Biomedical Labs., Inc. |
| K780005 | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 | Substantially Equivalent | Northeast Biomedical Labs., Inc. |
| K780004 | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 | Substantially Equivalent | Northeast Biomedical Labs., Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.