Clinical_toxicology
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
BIO-RAD LABORATORIES, INC.
FDA-cleared AI medical device
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.
FDA Submission Metadata
- Submission number
- K043341
- Decision date
- October 2005
- FDA panel
- Clinical Tcxicology
- Product code
- NVI
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Omics
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.