January 2025—Thermo Fisher Scientific has received FDA 510(k) clearance for the Applied BioSystems TaqPath COVID-19 diagnostic PCR kit. The kit was first introduced as an EUA test; the 510(k) clearance allows clinical and public health laboratories to convert to an in vitro diagnostic workflow. The kit is intended for use with nasopharyngeal and anterior nasal swab samples and includes assays and controls for the real-time PCR detection of RNA from SARS-CoV-2 emerging virus.
Results are delivered in as few as three hours.
Thermo Fisher Scientific, 800-955-6288