K-number	K181334
Device name	ADVIA Centaur Herpes-2 IgG
Applicant	Biokit, S.A.
Product code	MYF
Device class	Class II
Decision date	Aug 23, 2018
Decision	Substantially Equivalent
Regulation	866.3305

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur Herpes-2 IgG

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