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Access HBsAg CALIBRATOR

Beckman Coulter, Inc. · Model D22915 · UDI-DI 15099590806279

Prescription
0
510(k) clearances
0
Adverse events
0
Recalls
0
Facilities

Description

The Access HBsAg Calibrator is intended to calibrate the Access HBsAg and Access HBsAg Confirmatory assays for the in vitro qualitative detection and confirmation of hepatitis B surface antigen (HBsAg) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer.

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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.