Human IgG3 Subclass Single Dilution BINDARID™ Kits

GUDID 05051700010948

THE BINDING SITE GROUP LIMITED

Immunoglobulin G subclass (IgG subclass) IVD, kit, precipitation/immunodiffusion

• Primary Device ID: 05051700010948
• NIH Device Record Key: 3caeb826-782b-4803-9dbb-2a6a2f57663e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Human IgG3 Subclass Single Dilution BINDARID™ Kits
• Version Model Number: RN109.3
• Company DUNS: 347045614
• Company Name: THE BINDING SITE GROUP LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401214569500
• Email: info@bindingsite.co.uk

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051700010948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875356

FDA Product Code

• DEW: Igg, Antigen, Antiserum, Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Human IgG3 Subclass Single Dilution BINDARID™ Kits]

• 05051700010948: RN109.3
• 05051700010931: RN108.3