K-number	DEN120012
Device name	CDC DENV-1-4 REAL TIME RT-PCT ASSAY
Applicant	Centers for Disease Control and Prevention
Product code	OZB
Device class	Class II
Decision date	May 24, 2012
Decision	Not Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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

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