Human IgG1 Subclass Liquid Reagent Kit for use on

GUDID 05051700007634

THE BINDING SITE GROUP LIMITED

Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 05051700007634
• NIH Device Record Key: 667304dd-d6b0-4216-afac-23337f588f88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Human IgG1 Subclass Liquid Reagent Kit for use on
• Version Model Number: NK006.TB
• 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	05051700007634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012292

FDA Product Code

• CFN: Method, Nephelometric, Immunoglobulins (G, A, M)

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: 2018-09-14
• Device Publish Date: 2016-09-24

On-Brand Devices [Human IgG1 Subclass Liquid Reagent Kit for use on ]

• 05051700016377: NK006.10S
• 05051700007634: NK006.TB
• 05051700007627: NK006.T
• 05051700007603: NK006.IM
• 05051700007597: NK006.H
• 05051700007566: NK006.AU