ARTUS C. DIFFICILE QS-RGQ MDX KIT

C. Difficile Toxin Gene Amplification Assay

QIAGEN, GMBH

The following data is part of a premarket notification filed by Qiagen, Gmbh with the FDA for Artus C. Difficile Qs-rgq Mdx Kit.

Pre-market Notification Details

Device IDK133936
510k NumberK133936
Device Name:ARTUS C. DIFFICILE QS-RGQ MDX KIT
ClassificationC. Difficile Toxin Gene Amplification Assay
Applicant QIAGEN, GMBH 1201 CLOPPER RD Gaithersburg,  MD  20878
ContactKimberly Mapp
CorrespondentKimberly Mapp
QIAGEN, GMBH 1201 CLOPPER RD Gaithersburg,  MD  20878
Product CodeOZN  
CFR Regulation Number866.3130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-23
Decision Date2014-04-04
Summary:summary

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