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PerkinElmer Inc. (PKI) said Thursday that it has received an emergency use authorization from the U.S. Food and Drug Administration for the PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay.


RTTNews | Oct 7, 2021 08:47AM EDT

08:46 Thursday, October 7, 2021 (RTTNews.com) - PerkinElmer Inc. (PKI) said Thursday that it has received an emergency use authorization from the U.S. Food and Drug Administration for the PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay.

The company noted that laboratories can immediately begin using the single test for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus isolated from nasopharyngeal swabs, anterior nasal swabs and mid-turbinate swabs.

The company said a multi-analyte test such as the PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay allows laboratories to conserve precious resources by avoiding multiple tests on samples collected from individuals suspected of respiratory viral infection consistent with COVID-19.

PerkinElmer also has CE marking for a multi-analyte respiratory panel that tests for COVID-19 - the PKamp Respiratory SARS-CoV-2 RT-PCR Panel assay has clearance to be marketed as an in vitro diagnostic device in more than 30 countries by meeting the requirements of the European In Vitro Diagnostic Directive.

Read the original article on RTTNews ( https://www.rttnews.com/3231189/perkinelmer-receives-fda-emergency-nod-for-respiratory-sars-cov-2-panel.aspx)

For comments and feedback: contact editorial@rttnews.com

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