PRA

Variola Virus Nucleic Acid-Based Detection Assay

Product code

PRA

Device name

Variola Virus Nucleic Acid-Based Detection Assay

Device class

Class 2

21 CFR

21 CFR 866.3316

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).