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BioPlex 2200
BIO-RAD LABORATORIES, INC. · Model SW4.1_V1 · UDI-DI 00847865010948
2
510(k) clearances
24
Adverse events
1
Recalls
2
Facilities
Description
ToRC IgG Assay Protocol File CD, SW4.1_v1
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.