RIDA GENE Norovirus GI/GII

Reagents For Detection Of Norovirus Nucleic Acid

R-Biopharm AG

The following data is part of a premarket notification filed by R-biopharm Ag with the FDA for Rida Gene Norovirus Gi/gii.

Pre-market Notification Details

Device IDK171511
510k NumberK171511
Device Name:RIDA GENE Norovirus GI/GII
ClassificationReagents For Detection Of Norovirus Nucleic Acid
Applicant R-Biopharm AG An Der Neuen Bergstrabe 17 Darmstadt,  DE 64297
ContactAndreas Simons
CorrespondentPatricia Meinhardt
R-Biopharm Inc 870 Vossbrink Drive Washington,  MO  63090
Product CodePIQ  
CFR Regulation Number866.3990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-24
Decision Date2017-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049095160356 K171511 000

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