FDA product code GRH: Antigen, Ha (Including Ha Control), Rubeola
GRH is the FDA product code for antigen, ha (including ha control), rubeola. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel. Devices under GRH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Ha (Including Ha Control), Rubeola |
| Device class | Class I |
| Regulation | 21 CFR 866.3520 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GRH devices
openFDA lists no recalls for product code GRH.
Frequently asked questions
What is FDA product code GRH?
GRH is the FDA product code for antigen, ha (including ha control), rubeola. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel.
What device class is GRH?
Class I, regulation 21 CFR 866.3520. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GRH
- Run a recall and safety report across every GRH manufacturer
- Watch product code GRH 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.