Human Transferrin BINDARID™ Radial Immunodiffusion Kit

Basic Information

• Brand Name: Human Transferrin BINDARID™ Radial Immunodiffusion Kit
• Primary DI: 05051700010788
• Version / Model: RN070.3
• Company Name: THE BINDING SITE GROUP LIMITED
• Labeler DUNS: 347045614
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 2641ea0d-60cb-4f21-a5be-2c5cf11873f6
• Distribution End Date: 2020-02-29

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	866.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57675	Transferrin/transferrin isoform IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of transferrin or a transferrin isoform(s) [e.g., beta-2-transferrin, carbohydrate deficient transferrin] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051700010788	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius