Cleared Traditional

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

K221658 · Centers For Disease Control and Prevention · Microbiology
Jun 2022
Decision
2d
Days
Class 2
Risk

About This 510(k) Submission

K221658 is an FDA 510(k) clearance for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set, a Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set (Class II — Special Controls, product code PBK), submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on June 10, 2022, 2 days after receiving the submission on June 8, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3315.

Submission Details

510(k) Number K221658 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2022
Decision Date June 10, 2022
Days to Decision 2 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PBK — Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3315
Definition In Vitro Qualitative Detection Of Non-variola Orthopoxvirus Nucleic Acids Extracted From Human Specimens Or Viral Culture.

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