K-number	K233606
Device name	ADVIA Centaur EBV-VCA IgM
Applicant	Biokit, S.A.
Product code	LSE
Device class	Class I
Decision date	Aug 7, 2024
Decision	Substantially Equivalent
Regulation	866.3235

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur EBV-VCA IgM

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