NVI
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA definition
- 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K043341) | Bio-Rad Laboratories, Inc. | 2005-10-27 | + Add |
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Every clearance here is in the API, with alerts when new ones post.