FDA product code GNX: Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
GNX is the FDA product code for antigens, cf (including cf 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 18 510(k) submissions under GNX, from 14 different applicants. The average 510(k) review took 114 days (median 72). FDA has posted 10 recalls for GNX devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Cf (Including Cf 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 GNX clearance
Top GNX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quidel Corp. | 2 | 2013-07-05 |
| Whittaker Bioproducts, Inc. | 2 | 1990-06-27 |
| Microscan Div. Baxter Healthcare Corp. | 2 | 1987-06-26 |
| Institute Virion , Ltd. | 2 | 1985-09-26 |
| Alere Scarborough, Inc D/B/A Binax, Inc. | 1 | 2013-12-05 |
9 more applicants have GNX clearances. See the full list in Caduvo.
Most recent GNX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133411 | Alere Scarborough, Inc D/B/A Binax, Inc. | ALERE BINAXNOW INFLUENZA A & B CARD | 2013-12-05 | 28 |
| K132352 | Sa Scientific , Ltd. | SAS FLUALERT A & B, SAS INFLUENZA A TEST | 2013-08-22 | 24 |
| K131804 | Remel, Inc. | REMEL XPECT FLU A&B | 2013-07-12 | 23 |
| K131599 | Quidel Corporation | QUICK VUE INFLUENZA | 2013-07-05 | 32 |
| K131606 | Quidel Corp. | SOFIA INFLUENZA A+B FIA | 2013-07-05 | 32 |
Recalls for GNX devices
10 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-02-19.
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 GNX?
GNX is the FDA product code for antigens, cf (including cf 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 GNX?
Class I, regulation 21 CFR 866.3330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNX?
Across 18 cleared submissions the average was 114 days from receipt to decision (median 72).
Which companies have the most GNX clearances?
Quidel Corp. (2); Whittaker Bioproducts, Inc. (2); Microscan Div. Baxter Healthcare Corp. (2); Institute Virion , Ltd. (2); Alere Scarborough, Inc D/B/A Binax, Inc. (1).
Have GNX devices been recalled?
Yes: 10 product recalls across 5 recall events; the most recent began 2013-02-19.
Next steps
- Run an FDA pathway report with predicate devices for product code GNX
- Run a recall and safety report across every GNX manufacturer
- Watch product code GNX 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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