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NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization (EUA) for Becton Dickinson's PCR-based SARS-CoV-2 detection kit.

The kit is designed for the qualitative detection of nucleic acid from SARS-CoV-2 nasal, nasopharyngeal, and oropharyngeal swab samples. Nucleic acid is extracted using the company's BD MAX ExK TNA-3 kit, and the test runs on the BD Max system.

Use of the test is limited to CLIA-certified labs, the FDA said.

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