Hevylite® Human IgM Kappa Kit for use on the SPAPL

GUDID 05051700018272

THE BINDING SITE GROUP LIMITED

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

• Primary Device ID: 05051700018272
• NIH Device Record Key: 9e9ab100-5d76-417d-935e-9146eebff57b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hevylite® Human IgM Kappa Kit for use on the SPAPL
• Version Model Number: NK625.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	05051700018272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140686

FDA Product Code

• PDE: Immunoglobulin M Kappa 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: 2016-11-25

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