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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 the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2022-06-10 under 510(k) 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. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K221658.

When did Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Centers for Disease Control and Prevention as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260812Francisella tularensis Real-time PCR AssayK252072Francisella tularensis Real-time PCR assayK243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

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Related Devices (Code: PBK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and PreventionK221834Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and PreventionK181205Non-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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