ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA

Bordetella Pertussis Dna Assay System

MERIDIAN BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma.

Pre-market Notification Details

Device IDK133673
510k NumberK133673
Device Name:ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
ClassificationBordetella Pertussis Dna Assay System
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 CodeOZZ  
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-29
Decision Date2014-03-25
Summary:summary

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