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Roche acute Hepatitis B Test gets FDA PMA

The US Food and Drug Administration (FDA) has granted a premarket approval (PMA) to Roche's IgM antibody to hepatitis B core antigen (Anti-HBc IgM) assay.

The assay is designed to be used on the immunoassay module of the cobas 6000 analyzer series – cobas e 601 analyzer.

The Anti-HBc IgM assay is used to qualitatively determine IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma.

The company aims to use the assay with its electrochemiluminescence (ECL) technology, a light detection system which provides low-end sensitivity and broad dynamic measuring ranges.

The assay is also pending FDA approval for use on Roche’s cobas e 411 and Modular Analytics E170 analyzers.