FDA product code GRW: Antisera, All Fluorescent, Leptospira Spp.
GRW is the FDA product code for antisera, all fluorescent, leptospira spp.. It is a Class II device, regulated under 21 CFR 866.3350 and reviewed by the Microbiology panel. Devices under GRW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, All Fluorescent, 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 GRW devices
openFDA lists no recalls for product code GRW.
Frequently asked questions
What is FDA product code GRW?
GRW is the FDA product code for antisera, all fluorescent, leptospira spp.. It is a Class II device, regulated under 21 CFR 866.3350 and reviewed by the Microbiology panel.
What device class is GRW?
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 GRW
- Run a recall and safety report across every GRW manufacturer
- Watch product code GRW 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.