K-ASSAY® Factor XIII Reagent KAI-105

GUDID 00816426020467

For the quantitative determination of human coagulation factor XIII in plasma by immunoturbidimetric assay.

KAMIYA BIOMEDICAL COMPANY, LLC

Coagulation factor XIII IVD, reagent Coagulation factor XIII IVD, reagent Coagulation factor XIII IVD, reagent

• Primary Device ID: 00816426020467
• NIH Device Record Key: fdde864e-b085-41a0-a0d3-71963e7464c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-ASSAY® Factor XIII Reagent
• Version Model Number: KAI-105
• Catalog Number: KAI-105
• 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	00816426020467 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

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

• 00816426020535: For the quantitative determination of human coagulation factor XIII in plasma.
• 00816426020467: For the quantitative determination of human coagulation factor XIII in plasma by immunoturbidim