K-number	K033106
Device name	CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
Applicant	Trinity Biotech USA
Product code	MYF
Device class	Class II
Decision date	Jul 13, 2004
Decision	Substantially Equivalent
Regulation	866.3305

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Source

View the full FDA submission: accessdata.fda.gov

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CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT

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