FDA product code LSI: Antiserum, Blastomyces Dermatitidis, Other
LSI is the FDA product code for antiserum, blastomyces dermatitidis, other. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel. Devices under LSI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for LSI devices.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, 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 LSI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-01-20.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code LSI?
LSI is the FDA product code for antiserum, 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 LSI?
Class II, regulation 21 CFR 866.3060. Typical premarket route: 510(k) exempt.
Have LSI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-01-20.
Next steps
- Run an FDA pathway report with predicate devices for product code LSI
- Run a recall and safety report across every LSI manufacturer
- Watch product code LSI 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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