GLUTATHIONE REDUCTASE (GLUT RED)

Basic Information

• Brand Name: GLUTATHIONE REDUCTASE (GLUT RED)
• Primary DI: 05055273203400
• Version / Model: GR2368
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-03
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 6648f0e0-9414-4165-ac8e-8a851e832430

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
KQF	Assay, Glutathione Reductase	Hematology	864.7375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63351	Glutathione reductase IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glutathione reductase in a clinical specimen, using a spectrophotometry method. It is typically used to aid in the diagnosis of hepatic and malignant disease or assessment of nutrition (riboflavin status).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273203400	GS1