ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

MERIDIAN BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene Group B Streptococcus Carrot Broth Claim.

Pre-market Notification Details

Device IDK121044
510k NumberK121044
Device Name:ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
ClassificationNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Applicant MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
ContactMichelle L Smith
CorrespondentMichelle L Smith
MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
Product CodeNJR  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-06
Decision Date2012-05-01
Summary:summary

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