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BD Diagnostics HAI assay earns CE mark

BD Diagnostics has secured CE mark approval for its first healthcare-associated infection (HAI) assay, BD MAX MRSA assay.

According to the company, the BD MAX MRSA Assay is designed to be used on BD MAX automated molecular system to rapidly identify methicillin-resistant Staphylococcus aureus (MRSA) in patients.

The BD MAX System, which has dual functionality of open system and CE/IVD capabilities, provides clinicians with the best information, which enables them to make critical treatment and management decisions to improve patient care.

BD Diagnostics vice president and general manager Hilja Ibert said the BD MAX MRSA Assay on the BD MAX System provides significant laboratory efficiency and versatility to look into the increasing volume of molecular tests.