THE DDI SERODOT HERPES IGG TEST KIT

Antisera, Cf, Herpesvirus Hominis 1,2

DISEASE DETECTION INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for The Ddi Serodot Herpes Igg Test Kit.

Pre-market Notification Details

Device IDK875366
510k NumberK875366
Device Name:THE DDI SERODOT HERPES IGG TEST KIT
ClassificationAntisera, Cf, Herpesvirus Hominis 1,2
Applicant DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
ContactEl-badry, Phd
CorrespondentEl-badry, Phd
DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
Product CodeGQO  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-31
Decision Date1988-05-23

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