K-number	K854488
Device name	ORTHO HSV ANTIGEN ELISA TEST
Applicant	Ortho Diagnostic Systems, Inc.
Product code	GQN
Device class	Class II
Decision date	Feb 4, 1986
Decision	Substantially Equivalent
Regulation	866.3305

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View the full FDA submission: accessdata.fda.gov

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ORTHO HSV ANTIGEN ELISA TEST

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