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BioPlex 2200

BIO-RAD LABORATORIES, INC. · Model 6651650 · UDI-DI 00847865000444

OMI
2
510(k) clearances
24
Adverse events
1
Recalls
2
Facilities

Description

ToRC IgG Reagent Pack

Recalls

DateFirmReason
2010-12-22BioCheck IncProduct labels indicate that the products are for IVD use and they do not have an approved 510(k).

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.