FDA product code LSG: Candida Species, Antibody Detection
LSG is the FDA product code for candida species, antibody detection. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel. Devices under LSG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Candida Species, Antibody Detection |
| Device class | Class II |
| Regulation | 21 CFR 866.3165 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for LSG devices
openFDA lists no recalls for product code LSG.
Frequently asked questions
What is FDA product code LSG?
LSG is the FDA product code for candida species, antibody detection. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel.
What device class is LSG?
Class II, regulation 21 CFR 866.3165. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code LSG
- Run a recall and safety report across every LSG manufacturer
- Watch product code LSG 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.