FDA product code GQM: Antisera, Neutralization, Herpesvirus Hominis
GQM is the FDA product code for antisera, neutralization, herpesvirus hominis. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GQM, from 3 different applicants. The average 510(k) review took 92 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Neutralization, Herpesvirus Hominis |
| Device class | Class II |
| Regulation | 21 CFR 866.3305 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every GQM clearance
Top GQM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Enzo Biochem, Inc. | 1 | 1988-03-28 |
| Vibac Corp. | 1 | 1981-05-15 |
| Microbiological Assoc. | 1 | 1979-09-24 |
Most recent GQM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K875367 | Enzo Biochem, Inc. | COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV | 1988-03-28 | 88 |
| K810043 | Vibac Corp. | GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I | 1981-05-15 | 128 |
| K791397 | Microbiological Assoc. | HERPES EIA TEST KIT | 1979-09-24 | 59 |
Recalls for GQM devices
openFDA lists no recalls for product code GQM.
Frequently asked questions
What is FDA product code GQM?
GQM is the FDA product code for antisera, neutralization, herpesvirus hominis. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel.
What device class is GQM?
Class II, regulation 21 CFR 866.3305. Typical premarket route: 510(k).
How long does a 510(k) take for product code GQM?
Across 3 cleared submissions the average was 92 days from receipt to decision (median 88).
Which companies have the most GQM clearances?
Enzo Biochem, Inc. (1); Vibac Corp. (1); Microbiological Assoc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GQM
- Run a recall and safety report across every GQM manufacturer
- Watch product code GQM 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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