Variola virus Real-Time PCR Assay

DEN160016 is the FDA 510(k) clearance record for Variola virus Real-Time PCR Assay, a class II device, cleared for Centers For Disease Control and Prevention (CDC) on 2017-02-06 under FDA product code PRA (Variola Virus Nucleic Acid-Based Detection Assay). FDA's definition for product code PRA reads: "The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with...". FDA records list 6 510(k) clearances for Centers For Disease Control and Prevention (CDC), from 2014-05-22 to 2018-07-30. As of 2026-09-10, FDA records show no recalls naming DEN160016.