Human IgA Subclass NL BINDARID™ Radial Immunodiffu

GUDID 05051700010375

THE BINDING SITE GROUP LIMITED

Immunoglobulin A subclass (IgA subclass) IVD, kit, precipitation/immunodiffusion

• Primary Device ID: 05051700010375
• NIH Device Record Key: 37279c1f-5e81-472c-848c-ec0adcdc187a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Human IgA Subclass NL BINDARID™ Radial Immunodiffu
• Version Model Number: RK015
• 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: +441214569500
• 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	05051700010375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931806

FDA Product Code

• CZP: Iga, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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