CDC DENV-1-4 REAL TIME RT-PCT ASSAY

Dengue Nucleic Acid Amplification Assay (naat)

CENTERS FOR DISEASE CONTROL AND PREVENTION

The following data is part of a De Novo classification by Centers For Disease Control And Prevention with the FDA for Cdc Denv-1-4 Real Time Rt-pct Assay.

Pre-market Notification Details

DeNovo IDDEN120012
Device Name:CDC DENV-1-4 REAL TIME RT-PCT ASSAY
ClassificationDengue Nucleic Acid Amplification Assay (naat)
Applicant CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 Clifton Rd., N.e. Atlanta,  GA  30333
ContactHye-joo Kim
Product CodeOZB  
CFR Regulation Number866.3946 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK113336
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypePost-NSE
Date Received2012-03-12
Decision Date2012-05-24
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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