K-number	K911570
Device name	EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST
Applicant	Ortho Diagnostic Systems, Inc.
Product code	MCD
Device class	Class I
Decision date	Jun 10, 1991
Decision	Substantially Equivalent
Regulation	866.3235

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EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST

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