BD Gets FDA OK for Group B Strep MDx Assay | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Becton Dickinson today said that the US Food and Drug Administration has cleared for marketing its BD Max Group B Streptococcus Assay for detection of GBS DNA in Lim Broth cultures.

BD said that the test, which runs on its second-generation BD Max System, received CLIA moderate complexity test categorization. It said that the test is the only automated IVD method for PCR detection of GBS from Lim Broth with a moderate complexity categorization.

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