FDA product code GMN: Antigens, Cf, Toxoplasma Gondii
GMN is the FDA product code for antigens, cf, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GMN, from 3 different applicants. The average 510(k) review took 159 days (median 117).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Cf, Toxoplasma Gondii |
| Device class | Class II |
| Regulation | 21 CFR 866.3780 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GMN clearance
Top GMN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microbix Biosystems, Inc. | 1 | 1989-10-16 |
| Virion (U.S.), Inc. | 1 | 1987-10-30 |
| Volu Sol Medical Industries | 1 | 1979-09-24 |
Most recent GMN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894261 | Microbix Biosystems, Inc. | TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN | 1989-10-16 | 117 |
| K864981 | Virion (U.S.), Inc. | TOXOPLASMA GONDII | 1987-10-30 | 312 |
| K791456 | Volu Sol Medical Industries | AGGLUTINOTEST-TOXOPLASMOSIS | 1979-09-24 | 49 |
Recalls for GMN devices
openFDA lists no recalls for product code GMN.
Frequently asked questions
What is FDA product code GMN?
GMN is the FDA product code for antigens, cf, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel.
What device class is GMN?
Class II, regulation 21 CFR 866.3780. Typical premarket route: 510(k).
How long does a 510(k) take for product code GMN?
Across 3 cleared submissions the average was 159 days from receipt to decision (median 117).
Which companies have the most GMN clearances?
Microbix Biosystems, Inc. (1); Virion (U.S.), Inc. (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GMN
- Run a recall and safety report across every GMN manufacturer
- Watch product code GMN 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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