FDA product code GNS: Antisera, Hai, Influenza Virus A, B, C
GNS is the FDA product code for antisera, hai, influenza virus a, b, c. It is a Class I device, regulated under 21 CFR 866.3330 and reviewed by the Microbiology panel. FDA has cleared 9 510(k) submissions under GNS, from 2 different applicants. The average 510(k) review took 13 days (median 11).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Hai, Influenza Virus A, B, C |
| Device class | Class I |
| Regulation | 21 CFR 866.3330 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Top GNS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Northeast Biomedical Labs., Inc. | 5 | 1978-05-03 |
| Flow Laboratories, Inc. | 4 | 1978-02-28 |
Most recent GNS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780696 | Northeast Biomedical Labs., Inc. | GOAT ANTIINFLUENZA ANTISERA AUSSR | 1978-05-03 | 9 |
| K780697 | Northeast Biomedical Labs., Inc. | GOAT ANTI-INFLUENZA ANTISERA ATEXAS | 1978-05-03 | 9 |
| K780273 | Flow Laboratories, Inc. | INFLUENZA HI PRESERUM | 1978-02-28 | 11 |
| K780277 | Flow Laboratories, Inc. | INFLUENZA HI PRESERUM A/TEXAS | 1978-02-28 | 11 |
| K780274 | Flow Laboratories, Inc. | INFLUENZA HI ANTISERUM | 1978-02-28 | 11 |
Recalls for GNS devices
openFDA lists no recalls for product code GNS.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0008 — Administration of influenza virus vaccine
- Q2039 — Influenza virus vaccine, not otherwise specified
- Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu)
Frequently asked questions
What is FDA product code GNS?
GNS is the FDA product code for antisera, hai, influenza virus a, b, c. It is a Class I device, regulated under 21 CFR 866.3330 and reviewed by the Microbiology panel.
What device class is GNS?
Class I, regulation 21 CFR 866.3330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNS?
Across 9 cleared submissions the average was 13 days from receipt to decision (median 11).
Which companies have the most GNS clearances?
Northeast Biomedical Labs., Inc. (5); Flow Laboratories, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code GNS
- Run a recall and safety report across every GNS manufacturer
- Watch product code GNS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.