K-number	DEN140004
Device name	QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
Applicant	Diagnostic Hybrids, Inc.
Product code	PGI
Device class	Class II
Decision date	May 13, 2014
Decision	Not Substantially Equivalent
Regulation	866.3309

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View the full FDA submission: accessdata.fda.gov

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QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

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