Dx Focus: Becton Dickinson's GBS Assay Gets FDA OK | GenomeWeb

Becton Dickinson said this week that the US Food and Drug Administration has cleared its BD Max Group B Streptococcus Assay for detecting GBS DNA in Lim broth cultures.

BD said that the PCR-based in vitro diagnostic test runs on its second-generation BD Max System, and received CLIA moderate complexity test categorization.

The firm is also developing methicillin-resistant Staphylococcus aureus and Clostridium difficile assays to run on the BD Max system.

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