Freelite® Human Lambda Free Kit for use on the Roche Cobas Integra®

GUDID 05051700006460

THE BINDING SITE GROUP LIMITED

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

• Primary Device ID: 05051700006460
• NIH Device Record Key: 1b020aeb-eabb-45eb-b158-4d2bbcc9e7f5
• Commercial Distribution Discontinuation: 2019-04-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Freelite® Human Lambda Free Kit for use on the Roche Cobas Integra®
• Version Model Number: LK018.RI
• 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	05051700006460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070900

FDA Product Code

• DEH: Lambda, 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: 4
• Public Version Date: 2019-04-17
• Device Publish Date: 2016-09-24

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