C-Reactive Protein Kit for SPAPLUS

GUDID 05051700018456

THE BINDING SITE GROUP LIMITED

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 05051700018456
• NIH Device Record Key: bfe87038-cc0f-48a5-b0ef-27a68146bff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Reactive Protein Kit for SPAPLUS
• Version Model Number: NK044.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: +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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051700018456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161982

FDA Product Code

• DCN: System, Test, C-Reactive Protein

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: 2017-09-27

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