AccessGUDID - DEVICE: RIDASCREEN® Norovirus 3rd Generation (04049095030079)

GUDID

Device Identifier (DI) Information

Brand Name: RIDASCREEN® Norovirus 3rd Generation
Version or Model: C1401US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C1401US
Company Name: R-Biopharm AG

Primary DI Number: 04049095030079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 321850323 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUC	Norovirus Serological Reagent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN110001	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c0fb252-ac39-4c74-a009-b9f3ce105fe4
Public Version Date: April 22, 2024
Public Version Number: 4
DI Record Publish Date: May 08, 2019