Thermo Fisher Scientific has received 510(k) clearance from the US FDA for the Applied BioSystems TaqPath COVID-19 Diagnostic PCR Kit. 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. As an all-in-one solution, the combo kit includes a diagnostic PCR assay kit, diagnostic PCR control, and diagnostic PCR control dilution buffer. Results are delivered in as little as 3 hours.