VIDAS CMV IGM ASSAY

Antibody Igm,if, Cytomegalovirus Virus

BIOMERIEUX VITEK, INC.

The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Cmv Igm Assay.

Pre-market Notification Details

Device IDK933549
510k NumberK933549
Device Name:VIDAS CMV IGM ASSAY
ClassificationAntibody Igm,if, Cytomegalovirus Virus
Applicant BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland,  MA  02370
ContactVicki Anastasi
CorrespondentVicki Anastasi
BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland,  MA  02370
Product CodeLKQ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-22
Decision Date1994-08-02

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