← Back to catalogue

RIDA®GENE Norovirus GI/GII

FDA UDI

Class II (US FDA UDI)

by R-Biopharm AG

Identity

Trade Name
RIDA®GENE Norovirus GI/GII FDA UDI
Generic Name
Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
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. FDA UDI
Model / Reference
PG1445 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
PG1445 FDA UDI
Primary DI / UDI-DI
04049095160356 FDA UDI
510(k) Number
K171511 FDA UDI
FDA Product Code
PIQ FDA UDI
OOI FDA UDI
GMDN Term
Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3990 FDA UDI
862.2570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

RIDA®GENE Norovirus GI/GII by R-Biopharm AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
R-Biopharm AG

Sources (1)

  • FDA UDI 58c43060-8efb-4ece-98b0-3d888b1334ec 35 fields · synced May 30, 2026