FDA product code GNR: Antisera, Neutralization, Influenza Virus A, B, C
GNR is the FDA product code for antisera, neutralization, 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 1 510(k) submission under GNR. The average 510(k) review took 66 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Neutralization, 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 |
Compare with all 510(k) review times · Search every GNR clearance
Top GNR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zymetx, Inc. | 1 | 1999-03-04 |
Most recent GNR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K984596 | Zymetx, Inc. | VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES | 1999-03-04 | 66 |
Recalls for GNR devices
openFDA lists no recalls for product code GNR.
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 GNR?
GNR is the FDA product code for antisera, neutralization, 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 GNR?
Class I, regulation 21 CFR 866.3330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNR?
Across 1 cleared submissions the average was 66 days from receipt to decision (median 66).
Which companies have the most GNR clearances?
Zymetx, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GNR
- Run a recall and safety report across every GNR manufacturer
- Watch product code GNR 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.
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