INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

Influenza A Virus Subtype Differentiation 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 Influenza A Subtyping Kit, Cdc Human Influenza Virus Real-time Rt-pcr Diagnostic Panel.

Pre-market Notification Details

Device IDK140851
510k NumberK140851
Device Name:INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
ClassificationInfluenza A Virus Subtype Differentiation Nucleic Acid Assay
Applicant CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON ROAD, MAILSTOP D-30 Atlanta,  GA  30333
ContactCdr Yon Yu, Pharm.d.
CorrespondentCdr Yon Yu, Pharm.d.
CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON ROAD, MAILSTOP D-30 Atlanta,  GA  30333
Product CodeOEP  
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-03
Decision Date2014-04-25
Summary:summary

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