FDA Biologics (BLA & Biosimilars)Original article
Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm
RegulatoryElecsys HBsAg IIElecsys HBsAg II Auto ConfirmNeutral
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Summary
Roche announced intended use specifications for Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm immunoassays for the qualitative detection and confirmation of hepatitis B surface antigen in serum and plasma samples.
Importance:2/10
Sentiment:
0.00
diagnosticshepatitis Bimmunoassayregulatory
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Published by FDA Biologics (BLA & Biosimilars) on July 8, 2026 12:50 PM