FDA product code GML: Antisera, Fluorescent, Histoplasma Capsulatum
GML is the FDA product code for antisera, fluorescent, histoplasma capsulatum. It is a Class II device, regulated under 21 CFR 866.3320 and reviewed by the Microbiology panel. Devices under GML reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, Histoplasma Capsulatum |
| Device class | Class II |
| Regulation | 21 CFR 866.3320 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GML devices
openFDA lists no recalls for product code GML.
Frequently asked questions
What is FDA product code GML?
GML is the FDA product code for antisera, fluorescent, histoplasma capsulatum. It is a Class II device, regulated under 21 CFR 866.3320 and reviewed by the Microbiology panel.
What device class is GML?
Class II, regulation 21 CFR 866.3320. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GML
- Run a recall and safety report across every GML manufacturer
- Watch product code GML 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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