K-ASSAY® Factor XIII Control K204C-10M

GUDID 00816426021129

For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.

KAMIYA BIOMEDICAL COMPANY, LLC

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

• Primary Device ID: 00816426021129
• NIH Device Record Key: 075738b7-101b-4fb1-b14a-4810e0fb9813
• Commercial Distribution Discontinuation: 2019-12-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: K-ASSAY® Factor XIII Control
• Version Model Number: K204C-10M
• Catalog Number: K204C-10M
• 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	00816426021129 [Primary]

FDA Product Code

• DBT: Factor Xiii A, S, 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: 2019-12-27
• Device Publish Date: 2017-02-09

On-Brand Devices [K-ASSAY® Factor XIII Control]

• 00816426021129: For use as a consistent test sample of known concentration for monitoring assay conditions for F
• 00816426021099: For use as a consistent test sample of known concentration for monitoring assay conditions for F