Optilite® CH50 Reagent

GUDID 05051700021098

THE BINDING SITE GROUP LIMITED

Total complement activity (CH50) IVD, reagent

• Primary Device ID: 05051700021098
• NIH Device Record Key: 1c5af171-1a66-430f-b340-996514b5cf30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optilite® CH50 Reagent
• Version Model Number: NK095.OPT.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: 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
• Phone: +4401214569500
• Email: info@bindingsite.co.uk
• Phone: +4401214569500
• Email: info@bindingsite.co.uk
• Phone: +4401214569500
• Email: info@bindingsite.co.uk
• Phone: +4401214569500
• Email: info@bindingsite.co.uk
• Phone: +4401214569500
• Email: info@bindingsite.co.uk
• Phone: +4401214569500
• Email: info@bindingsite.co.uk
• Phone: +4401214569500
• Email: info@bindingsite.co.uk
• Phone: +4401214569500
• Email: info@bindingsite.co.uk
• Phone: +4401214569500
• Email: info@bindingsite.co.uk

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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• 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	05051700021098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150412

FDA Product Code

• DAE: Complement C9, Antigen, Antiserum, Control

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: 2024-11-28
• Device Publish Date: 2024-11-20

Devices Manufactured by THE BINDING SITE GROUP LIMITED

• 05051700021098 - Optilite® CH50 Reagent: 2024-11-28
• 05051700021098 - Optilite® CH50 Reagent: 2024-11-28
• 05051700019392 - Optilite® Low Level Total Protein Controls: 2024-11-07
• 05051700020534 - Optilite® Low Level Total Protein Calibrator: 2024-11-07
• 05051700020558 - Optilite® Low Level Total Protein Reagent: 2024-11-07
• 05051700021036 - Optilite® IgG3 Kit (x10): 2023-10-05
• 05051700021043 - Optilite® IgG4 Kit (x10): 2023-10-05
• 05051700016803 - Freelite® Kappa AMR Check Fluid SD: 2023-08-17
• 05051700016810 - Freelite® Lambda AMR Check Fluid SD: 2023-08-17