Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K181205 ↗

FDA Product Code

PBK

Device Class

Class II

Regulation

21 CFR Part 866.3315

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K190302 Active Cleared 27 Mar 2019

See all devices from Centers for Disease Control and Prevention →