FDA product code GRI: Antiserum, Neutralization, Rubeola
GRI is the FDA product code for antiserum, neutralization, rubeola. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel. Devices under GRI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Neutralization, Rubeola |
| Device class | Class I |
| Regulation | 21 CFR 866.3520 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GRI devices
openFDA lists no recalls for product code GRI.
Frequently asked questions
What is FDA product code GRI?
GRI is the FDA product code for antiserum, neutralization, rubeola. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel.
What device class is GRI?
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 GRI
- Run a recall and safety report across every GRI manufacturer
- Watch product code GRI 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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