Thermo Fisher Scientific Announces 510(k) Clearance of the Applied BioSystems TaqPath COVID-19 Diagnostic PCR Kit

Thermo Fisher Scientific has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the Applied BioSystems™ TaqPath™ COVID-19 Diagnostic PCR Kit. First introduced as an Emergency Use Authorized (EUA) test, the 510(k) clearance allows clinical and public health laboratories to convert to an in vitro diagnostic (IVD) workflow.  

Thermo Fisher Scientific is committed to its clinical customers in driving continuous innovation. The 510(k) cleared TaqPath COVID-19 Diagnostic PCR Kit is built from the same chemistry as the EUA kit that was used to test over one billion patient samples during the height of the COVID-19 pandemic.  

The kit is intended for use with 2 types of patient samples, nasopharyngeal and anterior nasal swabs, and it includes the necessary assays and controls for the real-time PCR detection of RNA from SARS-CoV-2 emerging virus. As new mutations continue to emerge, the TaqPath™ COVID-19 Diagnostic PCR Kit multi-gene target design (ORF1ab, N gene S gene) provides greater confidence in results to support an accurate diagnosis.