K-number	K192376
Device name	Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
Applicant	Diasorin Molecular, LLC
Product code	PGI
Device class	Class II
Decision date	Nov 26, 2019
Decision	Substantially Equivalent
Regulation	866.3309

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Source

View the full FDA submission: accessdata.fda.gov

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Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

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