CDC Human Influenza Virus Real- Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping

Influenza A And Influenza B Multiplex Nucleic Acid Assay

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

The following data is part of a premarket notification filed by Centers For Disease Control And Prevention (cdc) with the FDA for Cdc Human Influenza Virus Real- Time Rt-pcr Diagnostic Panel, Influenza A/h5 Subtyping.

Pre-market Notification Details

Device IDK153148
510k NumberK153148
Device Name:CDC Human Influenza Virus Real- Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
ClassificationInfluenza A And Influenza B Multiplex Nucleic Acid Assay
Applicant CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON ROAD, MS-C18 Atlanta,  GA  30329 -4027
ContactYon Yu
CorrespondentYon Yu
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON ROAD, MS-C18 Atlanta,  GA  30329 -4027
Product CodeOZE  
Subsequent Product CodeNSU
Subsequent Product CodeNXD
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-30
Decision Date2015-12-01
Summary:summary

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