K-ASSAY® D-Dimer Control K92C-4M

GUDID 00816426021273

For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer.

KAMIYA BIOMEDICAL COMPANY, LLC

Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control

• Primary Device ID: 00816426021273
• NIH Device Record Key: 55b4bc2e-8062-40c8-b842-2ba71e1770bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-ASSAY® D-Dimer Control
• Version Model Number: K92C-4M
• Catalog Number: K92C-4M
• Company DUNS: 197934250
• Company Name: KAMIYA BIOMEDICAL COMPANY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 206-575-8068
• Email: diagnostics@k-assay.com
• Phone: 206-575-8068
• Email: diagnostics@k-assay.com
• Phone: 206-575-8068
• Email: diagnostics@k-assay.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816426021273 [Primary]

FDA Product Code

• GGN: Plasma, Coagulation 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: 2018-07-02
• Device Publish Date: 2018-05-30

On-Brand Devices [K-ASSAY® D-Dimer Control]

• 00816426021273: For use as a consistent test sample of known concentration for monitoring assay conditions for D
• 00816426021266: For use as a consistent test sample of known concentration for monitoring assay conditions for D