FDA.reportPublic FDA data

RIDA®GENE Norovirus GI/GII

Primary DI
04049095160356
Brand
RIDA®GENE Norovirus GI/GII
Company
R-Biopharm AG
Model
PG1445
Catalog number
PG1445
Device description
The RIDA®GENE Norovirus GI/GII assay, performed on the Applied Biosystems® 7500 Fast Dx System, is a real-time RT-PCR in vitro diagnostic test for the qualitative detection and differentiation of norovirus genogroup I (GI) and II (GII) RNA from raw or unpreserved stool specimens collected from individuals with signs and symptoms of acute gastroenteritis.
Published
2019-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System
PIQReagents For Detection Of Norovirus Nucleic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
PIQReagents For Detection Of Norovirus Nucleic AcidMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171511000RIDA GENE Norovirus GI/GIIR-Biopharm AG2017-08-21PIQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049095160356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049095160356040490951603564049095160356

GMDN Terms#

Term, Definition table
TermDefinition
Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Norovirus in a clinical specimen, using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
321850323
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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