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FDA 510(k)

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

K-Number: K221658 · 2022-06-10

ApplicantCenters for Disease Control and Prevention
Decision Date2022-06-10
Product CodePBK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is a medical device manufactured by Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2022-06-10 under approval number K221658. The device is classified under product code PBK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Centers for Disease Control and Prevention. The 510(k) number is K221658.

When was Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set approved by the FDA?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set received FDA 510(k) clearance on 2022-06-10, under approval number K221658.

What company makes Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is manufactured by Centers for Disease Control and Prevention.

What is the FDA product code for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

The FDA product code for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is PBK.

Related PubMed Literature

PMID: 32750323 Endoscopic transmission of carbapenem-resistant Enterobacteriaceae: implications for U.S. Food and Drug Administration approval and postmarket surveillance of endoscopic devices. Gastrointestinal endoscopy (2021)

Other Devices by Centers for Disease Control and Prevention

K172091CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit DEN070001NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET K181205Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set K192871B. anthracis Real-time PCR Assay K190302CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

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Related Devices (Code: PBK)

DEN070001NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SETCenters for Disease Control and Prevention K181205Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention K221834Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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