CDC 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

Influenza A And Influenza B Multiplex Nucleic Acid Assay

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 Cdc 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.

Pre-market Notification Details

Device IDK200370
510k NumberK200370
Device Name:CDC 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
ClassificationInfluenza A And Influenza B Multiplex Nucleic Acid Assay
Applicant Centers For Disease Control And Prevention 1600 Clifton Rd; MS H24-11 Atlanta,  GA  30329
ContactYon Yu
CorrespondentYon Yu
Centers For Disease Control And Prevention 1600 Clifton Rd; MS H24-11 Atlanta,  GA  30329
Product CodeOZE  
Subsequent Product CodeNSU
Subsequent Product CodeNXD
Subsequent Product CodeOEP
Subsequent Product CodeOOI
Subsequent Product CodeOQW
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-14
Decision Date2020-03-10

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