Quest Diagnostics’ Simplexa Test Kit Gets FDA Clearance for 53 Additional Virus Strains

Quest Diagnostics (DGX), a provider of diagnostic testing information services, said Tuesday that its Focus Diagnostics subsidiary has received a 510(k) clearance from the U.S. Food and Drug Administration for its Simplexa Flu A/B &RSV test kit for 46 additional influenza A and influenza B virus strains and seven additional respiratory syncytial virus (RSV) strains.

The Simplexa test kit previously received in July 2012 a 510(k) initial clearance for select virus strains, and some additional strains in 2014. The the latest approval, the test kit can detect a total of 92 influenza and RSV virus strains.

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Companies: Quest Diagnostics Incorporated
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