FDA product code GSR: Antisera, Fluorescent, Pseudomonas Pseudomallei
GSR is the FDA product code for antisera, fluorescent, pseudomonas pseudomallei. It is a Class II device, regulated under 21 CFR 866.3415 and reviewed by the Microbiology panel. Devices under GSR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, Pseudomonas Pseudomallei |
| Device class | Class II |
| Regulation | 21 CFR 866.3415 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GSR devices
openFDA lists no recalls for product code GSR.
Frequently asked questions
What is FDA product code GSR?
GSR is the FDA product code for antisera, fluorescent, pseudomonas pseudomallei. It is a Class II device, regulated under 21 CFR 866.3415 and reviewed by the Microbiology panel.
What device class is GSR?
Class II, regulation 21 CFR 866.3415. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GSR
- Run a recall and safety report across every GSR manufacturer
- Watch product code GSR 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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