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

Assay, Nucleic Acid Amplification, Bacillus Anthracis

Centers For Disease Control And Prevention

The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set.

Pre-market Notification Details

Device IDK221658
510k NumberK221658
Device Name:Non-variola Orthopoxvirus Real-time PCR Primer And Probe Set
ClassificationAssay, Nucleic Acid Amplification, Bacillus Anthracis
Applicant Centers For Disease Control And Prevention 1600 Clifton Road NE, MS: H24-11 Atlanta,  GA  30329
ContactJulie Villanueva, PhD
CorrespondentJulie Villanueva, PhD
Centers For Disease Control And Prevention 1600 Clifton Road NE, MS: H24-11 Atlanta,  GA  30329
Product CodeNHT  
CFR Regulation Number866.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-08
Decision Date2022-06-10

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