Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit is an FDA 510(k)-cleared medical device (K233453) manufactured by Life Technologies Corporation. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 2024. Regulation: 8.