FDA product code LSH: Antigen, Blastomyces Dermatitidis, Other
LSH is the FDA product code for antigen, blastomyces dermatitidis, other. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel. Devices under LSH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Blastomyces Dermatitidis, Other |
| Device class | Class II |
| Regulation | 21 CFR 866.3060 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for LSH devices
openFDA lists no recalls for product code LSH.
Frequently asked questions
What is FDA product code LSH?
LSH is the FDA product code for antigen, blastomyces dermatitidis, other. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel.
What device class is LSH?
Class II, regulation 21 CFR 866.3060. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code LSH
- Run a recall and safety report across every LSH manufacturer
- Watch product code LSH 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.