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NEW YORK – BioMeriéux subsidiary BioFire Diagnostics has been granted de novo clearance from the US Food and Drug Administration for its Respiratory Panel 2.1, the agency said on Wednesday. The test is the first SARS-CoV-2 diagnostic to transition from an Emergency Use Authorization status and be permitted to be marketed beyond the public health emergency.

Janet Woodcock, FDA acting commissioner, called the de novo clearance "a great demonstration" of the FDA's efforts to protect public health.

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