Immunoglobulin Isotypes (GAM) for the EXENT Analyser

GUDID 05051700021050

THE BINDING SITE GROUP LIMITED

Multiple monoclonal immunoglobulin isotype IVD, kit, mass spectrometric immunoassay

• Primary Device ID: 05051700021050
• NIH Device Record Key: 8fb7660f-9931-42af-a6f8-244eee12d35b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immunoglobulin Isotypes (GAM) for the EXENT Analyser
• Version Model Number: MSR801.M.A
• 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: false
• 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: +441214569500
• Email: info@bindingsite.com
• Phone: +441214569500
• Email: info@bindingsite.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051700021050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250159

FDA Product Code

• SGG: Mass Spectrometric, Immunoglobulins (G, A, M, D, E)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-05
• Device Publish Date: 2025-11-27

Devices Manufactured by THE BINDING SITE GROUP LIMITED

• 05051700020602 - EXENT® Immunoglobulin Isotypes (GAM) Control Pack: 2025-12-05
• 05051700020640 - EXENT® Diluent 1: 2025-12-05
• 05051700020657 - EXENT® Elution buffer 1: 2025-12-05
• 05051700020664 - EXENT® HCCA MALDI Matrix Pack: 2025-12-05
• 05051700020671 - EXENT® Mass calibration standard 1: 2025-12-05
• 05051700020688 - EXENT® Disposable MALDI plate pack: 2025-12-05
• 05051700020695 - EXENT® Wash solution 1: 2025-12-05
• 05051700020886 - EXENT® Analyser: 2025-12-05