Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
The Influenza Virus A, B, and C HA (Hemagglutination) Antigens (Including HA Control) are viral antigens used in hemagglutination and hemagglutination inhibition tests to characterize influenza virus strains and detect anti-influenza antibodies in patient sera. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GNT, regulated under 21 CFR 866.3330 in the Microbiology specialty.
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Basic Information
- Product Code
- GNT
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950838 | VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES | Jun 17, 1996 | Substantially Equivalent | Zymetx, Inc. |
| K913828 | QTEST INFLUENZA A | Sep 23, 1991 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K902609 | DIRECTIGEN FLU A | Sep 10, 1990 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K780275 | INFLUENZA HA ANTIGEN A/USSR | Feb 28, 1978 | Substantially Equivalent | Flow Laboratories, Inc. |
| K780272 | INFLUENZA HA ANTIGEN | Feb 28, 1978 | Substantially Equivalent | Flow Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.