K-number	K152353
Device name	SeraQuest HSV Type 2 Specific IgG
Applicant	Quest International, Inc.
Product code	MYF
Device class	Class II
Decision date	May 13, 2016
Decision	Substantially Equivalent
Regulation	866.3305

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Source

View the full FDA submission: accessdata.fda.gov

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SeraQuest HSV Type 2 Specific IgG

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