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K-ASSAY® Haptoglobin Reagent

KAMIYA BIOMEDICAL COMPANY, LLC · Model KAI-022 · UDI-DI 00816426020153

DAD Prescription
1
510(k) clearances
1
Adverse events
1
Recalls
31
Facilities

Description

For the quantitative determination of human haptoglobin in serum by immunoturbidimetric assay.

Recalls

DateFirmReason
2018-05-16Abbott Laboratories, IncAn update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

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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.