Freelite® Human Kappa Free Kit for use on the Beck

GUDID 05051700006323

THE BINDING SITE GROUP LIMITED

Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 05051700006323
• NIH Device Record Key: 76b56bb7-65bb-4121-814d-8e8eb146ffcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freelite® Human Kappa Free Kit for use on the Beck
• Version Model Number: LK016.IM
• 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	05051700006323 [Primary]

FDA Product Code

• DFH: Kappa, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Freelite® Human Kappa Free Kit for use on the Beck]

• 05051700006323: LK016.IM
• 05051700006286: LK016.AU