FDA product code LGA: Device, Oxidase Test For Gonorrhea
LGA is the FDA product code for device, oxidase test for gonorrhea. It is a Class III device, regulated under 21 CFR 866.2420 and reviewed by the Microbiology panel. Devices under LGA reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Oxidase Test For Gonorrhea |
| Device class | Class III |
| Regulation | 21 CFR 866.2420 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | PMA |
Recalls for LGA devices
openFDA lists no recalls for product code LGA.
Frequently asked questions
What is FDA product code LGA?
LGA is the FDA product code for device, oxidase test for gonorrhea. It is a Class III device, regulated under 21 CFR 866.2420 and reviewed by the Microbiology panel.
What device class is LGA?
Class III, regulation 21 CFR 866.2420. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LGA
- Run a recall and safety report across every LGA manufacturer
- Watch product code LGA 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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