PRA

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Variola Virus Nucleic Acid-Based Detection Assay

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3316

Medical specialty

Microbiology

FDA 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.

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