FDA product code GRX: Antisera, All Leptospira Spp.
GRX is the FDA product code for antisera, all leptospira spp.. It is a Class II device, regulated under 21 CFR 866.3350 and reviewed by the Microbiology panel. Devices under GRX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, All Leptospira Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3350 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GRX devices
openFDA lists no recalls for product code GRX.
Frequently asked questions
What is FDA product code GRX?
GRX is the FDA product code for antisera, all leptospira spp.. It is a Class II device, regulated under 21 CFR 866.3350 and reviewed by the Microbiology panel.
What device class is GRX?
Class II, regulation 21 CFR 866.3350. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GRX
- Run a recall and safety report across every GRX manufacturer
- Watch product code GRX 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.