FDA product code GNG: Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
GNG is the FDA product code for antigens, cf (including cf control), coxsackievirus a 1-24, b 1-6. It is a Class I device, regulated under 21 CFR 866.3145 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GNG, from 2 different applicants. The average 510(k) review took 73 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6 |
| Device class | Class I |
| Regulation | 21 CFR 866.3145 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GNG clearance
Top GNG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Virion (U.S.), Inc. | 1 | 1992-06-29 |
| Hillcrest Biologicals | 1 | 1985-03-05 |
Most recent GNG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921618 | Virion (U.S.), Inc. | COXSACKIE VIRUS B1-B6 CF ANTIGENS | 1992-06-29 | 84 |
| K850003 | Hillcrest Biologicals | COXSACKIE B SERIES CF ANTIGENS | 1985-03-05 | 62 |
Recalls for GNG devices
openFDA lists no recalls for product code GNG.
Frequently asked questions
What is FDA product code GNG?
GNG is the FDA product code for antigens, cf (including cf control), coxsackievirus a 1-24, b 1-6. It is a Class I device, regulated under 21 CFR 866.3145 and reviewed by the Microbiology panel.
What device class is GNG?
Class I, regulation 21 CFR 866.3145. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNG?
Across 2 cleared submissions the average was 73 days from receipt to decision (median 73).
Which companies have the most GNG clearances?
Virion (U.S.), Inc. (1); Hillcrest Biologicals (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GNG
- Run a recall and safety report across every GNG manufacturer
- Watch product code GNG 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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