IBSchek IVD-1-Chek

GUDID 00856820008005

Capillary blood collection convenience kit

COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.

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• Primary Device ID: 00856820008005
• NIH Device Record Key: af66be35-2b5e-4682-9b6a-592012fb7149
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IBSchek
• Version Model Number: IVD-1-Chek
• Catalog Number: IVD-1-Chek
• Company DUNS: 080680537
• Company Name: COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com
• Phone: 8882585966
• Email: quality@commdx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856820008005 [Primary]

FDA Product Code

• PQD: Blood Specimen Collection Convenience Kit (Excludes Hiv)

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: 2018-06-18
• Device Publish Date: 2018-05-17