Name: Predicase
Price: 199 USD

K-number	K151046
Device name	illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
Applicant	Meridian Bioscience, Inc.
Product code	PGI
Device class	Class II
Decision date	Jul 17, 2015
Decision	Substantially Equivalent
Regulation	866.3309

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Source

View the full FDA submission: accessdata.fda.gov

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illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10

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