SEROCARD HSV IGG ANTIBODY TEST KIT

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

DISEASE DETECTION INTERNATIONAL, INC.

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

Pre-market Notification Details

Device IDK903070
510k NumberK903070
Device Name:SEROCARD HSV IGG ANTIBODY TEST KIT
ClassificationEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
Applicant DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine,  CA  92718
ContactJulie Whiteside
CorrespondentJulie Whiteside
DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine,  CA  92718
Product CodeLGC  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-12
Decision Date1990-08-09

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