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Access anti-HAV IgM Calibrator

Beckman Coulter, Inc. · Model D25835 · UDI-DI 15099590806453

QCH Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
15
Facilities

Description

The Access anti-HAV IgM Calibrator is intended to calibrate the Access anti-HAV IgM assay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer.

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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.