Product code PRA— Microbiology

“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 other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government.”

FDA has cleared 1 device under product code PRA, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• Centers For Disease Control and Prevention (CDC)1 clearance

• DEN160016 — Variola virus Real-Time PCR AssayCenters For Disease Control and Prevention (CDC)·2017-02-06