Freelite® Kappa AMR Check Fluid SD

GUDID 05051700016803

THE BINDING SITE GROUP LIMITED

Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control Kappa/lambda light chain immunoglobulin IVD, control

• Primary Device ID: 05051700016803
• NIH Device Record Key: a0723518-6358-43b0-a508-9510c550ae26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freelite® Kappa AMR Check Fluid SD
• Version Model Number: BP538.SD
• Company DUNS: 347045614
• Company Name: THE BINDING SITE GROUP LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• Email: info@bindingsite.co.uk
• Phone: +441214569500
• 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
• 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
• 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	05051700016803 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2023-08-17
• Device Publish Date: 2023-08-09

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• 05051700016810 - Freelite® Lambda AMR Check Fluid SD: 2023-08-17
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• 05051700015974 - IgD AMR Fluid: 2023-06-15
• 05051700015981 - B2M AMR Fluid: 2023-06-15