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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » Luminex Submits Verigene II Respiratory Assay for FDA Clearance

Luminex Submits Verigene II Respiratory Assay for FDA Clearance

Feb 24, 2020
|
staff reporter

NEW YORK – Luminex announced Monday that it has applied to the US Food and Drug Administration for 510(k) clearance of the Verigene II Respiratory Flex Assay (RSP Flex), a multiplexed test for simultaneous detection and identification of common viruses and bacteria from nasopharyngeal swabs obtained from a person suspected of having a respiratory tract infection.

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