PBK · Class II · 21 CFR 866.3315

FDA Product Code PBK: Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set

Monkeypox and related orthopoxvirus infections require rapid laboratory confirmation. FDA product code PBK covers non-variola orthopoxvirus real-time PCR assays.

These molecular tests detect and identify non-variola orthopoxvirus DNA — including monkeypox virus — from skin lesion specimens, vesicular fluid, and other samples. They are essential tools for outbreak response and infection control in mpox outbreaks.

PBK devices are Class II medical devices, regulated under 21 CFR 866.3315 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Centers For Disease Control and Prevention.

3
Total
3
Cleared
3d
Avg days
2022
Since

List of Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Aug 30, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K222558
Centers For Disease Control and Prevention
Microbiology · 6d
Cleared Jun 24, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221834
Centers For Disease Control and Prevention
Microbiology · 1d
Cleared Jun 10, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221658
Centers For Disease Control and Prevention
Microbiology · 2d

How to use this database

This page lists all FDA 510(k) submissions for Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set devices (product code PBK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →