Human Alpha 1 Antitrypsin NL BINDARID™ Kit

GUDID 05051700010696

THE BINDING SITE GROUP LIMITED

Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion Alpha-1-antitrypsin (protease inhibitor) IVD, kit, precipitation/immunodiffusion

• Primary Device ID: 05051700010696
• NIH Device Record Key: 742eda91-d631-4ed2-947c-d2c74206f3c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Human Alpha 1 Antitrypsin NL BINDARID™ Kit
• Version Model Number: RN034.3
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051700010696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913666

FDA Product Code

• DEM: Alpha-1-Antitrypsin, Antigen, Antiserum, Control

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: 2023-07-07
• Device Publish Date: 2023-06-29

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