RIDASCREEN® Norovirus 3rd Generation

Basic Information

• Brand Name: RIDASCREEN® Norovirus 3rd Generation
• Primary DI: 04049095030079
• Version / Model: C1401US
• Catalog Number: C1401US
• Company Name: R-Biopharm AG
• Labeler DUNS: 321850323
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-08
• Public Version: 3
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: 0c0fb252-ac39-4c74-a009-b9f3ce105fe4

Device Description

The RIDASCREEN® Norovirus 3rd Generation EIA test is a qualitative enzyme immunoassay (EIA) intended for the detection of selected genogroup I (GI.1, GI.2, GI.3, GI.4, GI.7) and genogroup II (GII.1, GII.2, GII.3, GII.4, GII.5, GII.6, GII.7, GII.8, GII.10, GII.12, GII.13, GII.14, GII.17) norovirus strains in human feces as an aid in investigating the cause of acute gastroenteritis outbreaks.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUC	Norovirus Serological Reagent	Microbiology	866.3395	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47896	Norovirus antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Norovirus in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049095030079	GS1