1 device · 1 company · 2005
Product code NVI: Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
1 device under product code NVI, 2005, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (0 of 1 here), the regulation, and MAUDE report counts by product code.
Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease. 21 CFR 862.3100, Class II. The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests. MAUDE held 1 adverse-event report against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUK043341 · 510(k) | BIO-RAD LABORATORIES, INC. | Clinical Toxcicology | database entry |
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