K-number	DEN160016
Device name	Variola virus Real-Time PCR Assay
Applicant	Centers For Disease Control and Prevention (CDC)
Product code	PRA
Device class	Class II
Decision date	Feb 6, 2017
Decision	Not Substantially Equivalent
Regulation	866.3316

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Source

View the full FDA submission: accessdata.fda.gov

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Variola virus Real-Time PCR Assay

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