FDA product code GMR: Sera, Reactive And Non-Specific Control, Fta-Abs Test
GMR is the FDA product code for sera, reactive and non-specific control, fta-abs test. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel. Devices under GMR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Sera, Reactive And Non-Specific Control, 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 GMR devices
openFDA lists no recalls for product code GMR.
Frequently asked questions
What is FDA product code GMR?
GMR is the FDA product code for sera, reactive and non-specific control, 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 GMR?
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 GMR
- Run a recall and safety report across every GMR manufacturer
- Watch product code GMR 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.