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K-ASSAY® Alpha-1 Microglobulin Reagent

KAMIYA BIOMEDICAL COMPANY, LLC · Model KAI-056 · UDI-DI 00816426020283

MGA Prescription
2
510(k) clearances
0
Adverse events
1
Recalls
8
Facilities

Description

For the quantitative determination of human alpha-1 microglobulin in urine, serum and plasma by immunoturbidimetric assay.

Recalls

DateFirmReason
2008-09-17Kamiya Biomedical Company, LLCStandardization of the reagent performance data did not match the standardization used to assign the calibrator values.

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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.