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a1-Microglobulin ELISA

DRG International Inc · Model EIA-5100 · UDI-DI 00840239051004

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

Description

The Assay is intended for the quantitative determination of a1-Microglobulin in serum, plasma and urine.

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.