BD Receives Second FDA’s Emergency Use Authorization for its New Molecular Diagnostic Test to Detect COVID-19

Shots:

• The US FDA has granted EUA to the BD’s molecular diagnostic test for COVID-19 that provides results in 2-3hrs. The BD SARS-CoV-2 Reagent Kit for BD MAX System has been CE marked to the IVD Directive (98/79/EC)
• The test is run on the BD MAX System to augment supply from existing collaboration with BioGX and CerTest and is based on the CDC assay design. The BD MAX system is a molecular diagnostic platform, used in multiple laboratories across the globe and can analyze hundreds of samples over a 24hrs period
•  The BD MAX Systems are installed in hospital laboratories to reduce the time and complexity to send samples to a reference lab. The assay is based on RNA targeting sequences and real-time PCR detection method and can be ordered by the hospital and laboratories through BD’s sales representative

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