Hevylite® Human IgM Lambda Kit for use on the SPAP

GUDID 05051700018289

THE BINDING SITE GROUP LIMITED

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 05051700018289
• NIH Device Record Key: 14e4f529-244e-45f8-aa4e-5f55b8e2c6b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hevylite® Human IgM Lambda Kit for use on the SPAP
• Version Model Number: NK626.S.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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051700018289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140686

FDA Product Code

• PDF: Immunoglobulin M Lambda Heavy And Light Chain Combined

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-04

Devices Manufactured by THE BINDING SITE GROUP LIMITED

• 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
• 05051700002059 - Freelite® Panel Sample Set: 2023-07-07
• 05051700010696 - Human Alpha 1 Antitrypsin NL BINDARID™ Kit: 2023-07-07
• 05051700015974 - IgD AMR Fluid: 2023-06-15
• 05051700015981 - B2M AMR Fluid: 2023-06-15