Variola virus Real-Time PCR Assay

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

DEN160016 ↗

FDA Product Code

PRA

Device Class

Class II

Regulation

21 CFR Part 866.3316

Advisory Committee

Microbiology

FDA Decision

DENG De Novo granted

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See all devices from Centers for Disease Control and Prevention →