EBV(EPSTEIN-BARR VIRUS) TEST KIT

Antiserum, Cf, Epstein-barr Virus

IMMUNO-DIAGNOSTIC PRODUCTS, INC.

The following data is part of a premarket notification filed by Immuno-diagnostic Products, Inc. with the FDA for Ebv(epstein-barr Virus) Test Kit.

Pre-market Notification Details

Device IDK854207
510k NumberK854207
Device Name:EBV(EPSTEIN-BARR VIRUS) TEST KIT
ClassificationAntiserum, Cf, Epstein-barr Virus
Applicant IMMUNO-DIAGNOSTIC PRODUCTS, INC. P.O. BOX 193 54 SOUTH 130 EAST North Salt Lake,  UT  84054
ContactNadeem M Muna
CorrespondentNadeem M Muna
IMMUNO-DIAGNOSTIC PRODUCTS, INC. P.O. BOX 193 54 SOUTH 130 EAST North Salt Lake,  UT  84054
Product CodeGNP  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-10-16
Decision Date1986-04-24

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