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FDA 510(k) K222558 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
FDA 510(k) index record K222558. Device: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set. Applicant as listed: Centers for Disease Control and Prevention. Decision date: 2022-08-30.
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"device_name": "Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K222558.
Device name: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set. Applicant as listed: Centers for Disease Control and Prevention.
Decision date: 2022-08-30. Decision wording: Substantially Equivalent.
Product code: PBK. Regulation: 21 CFR 866.3315. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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