FDA product code GNT: Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
GNT is the FDA product code for antigens, ha (including ha control), 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 5 510(k) submissions under GNT, from 3 different applicants. The average 510(k) review took 124 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Ha (Including Ha Control), 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 GNT clearance
Top GNT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1991-09-23 |
| Flow Laboratories, Inc. | 2 | 1978-02-28 |
| Zymetx, Inc. | 1 | 1996-06-17 |
Most recent GNT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950838 | Zymetx, Inc. | VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES | 1996-06-17 | 479 |
| K913828 | Bd Becton Dickinson Vacutainer Systems Preanalytic | QTEST INFLUENZA A | 1991-09-23 | 28 |
| K902609 | Bd Becton Dickinson Vacutainer Systems Preanalytic | DIRECTIGEN FLU A | 1990-09-10 | 90 |
| K780272 | Flow Laboratories, Inc. | INFLUENZA HA ANTIGEN | 1978-02-28 | 11 |
| K780275 | Flow Laboratories, Inc. | INFLUENZA HA ANTIGEN A/USSR | 1978-02-28 | 11 |
Recalls for GNT devices
openFDA lists no recalls for product code GNT.
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 GNT?
GNT is the FDA product code for antigens, ha (including ha control), 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 GNT?
Class I, regulation 21 CFR 866.3330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNT?
Across 5 cleared submissions the average was 124 days from receipt to decision (median 28).
Which companies have the most GNT clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (2); Flow Laboratories, Inc. (2); Zymetx, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GNT
- Run a recall and safety report across every GNT manufacturer
- Watch product code GNT 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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