LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Hsv-2 Type Specific Igg Assay, Control Hsv-2 Igg.

Pre-market Notification Details

Device IDK081687
510k NumberK081687
Device Name:LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
ClassificationEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
ContactCarol A Depouw
CorrespondentCarol A Depouw
DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
Product CodeMYF  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-17
Decision Date2008-11-10
Summary:summary

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