ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA

Test, Antigen, Nuclear, Epstein-barr Virus

ORTHO DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho*epstein-barr Virus Ebna-iff Antibody Elisa.

Pre-market Notification Details

Device IDK930002
510k NumberK930002
Device Name:ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
ClassificationTest, Antigen, Nuclear, Epstein-barr Virus
Applicant ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria,  CA  93013
ContactKim W Gray
CorrespondentKim W Gray
ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria,  CA  93013
Product CodeLLM  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-04
Decision Date1993-07-16

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