FDA product code GMX: Antisera, Fluorescent Antibody For Fta-Abs Test
GMX is the FDA product code for antisera, fluorescent antibody for fta-abs test. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel. Devices under GMX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent Antibody For Fta-Abs Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3830 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GMX devices
openFDA lists no recalls for product code GMX.
Frequently asked questions
What is FDA product code GMX?
GMX is the FDA product code for antisera, fluorescent antibody for fta-abs test. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel.
What device class is GMX?
Class II, regulation 21 CFR 866.3830. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GMX
- Run a recall and safety report across every GMX manufacturer
- Watch product code GMX 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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