VIDAS B.R.A.H.M.S. PCT ASSAY

Antigen, Inflammatory Response Marker, Sepsis

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas B.r.a.h.m.s. Pct Assay.

Pre-market Notification Details

Device IDK071146
510k NumberK071146
Device Name:VIDAS B.R.A.H.M.S. PCT ASSAY
ClassificationAntigen, Inflammatory Response Marker, Sepsis
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactNikita S Mapp
CorrespondentNikita S Mapp
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeNTM  
CFR Regulation Number866.3210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-24
Decision Date2007-10-11
Summary:summary

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