K-ASSAY® Factor XIII Calibrator KAI-106C

GUDID 00816426020719

For the calibration of the K-ASSAY® Factor XIII assay.

KAMIYA BIOMEDICAL COMPANY, LLC

Coagulation factor XIII IVD, calibrator Coagulation factor XIII IVD, calibrator Coagulation factor XIII IVD, calibrator

• Primary Device ID: 00816426020719
• NIH Device Record Key: 7d7eb821-49c3-4c2a-ab12-f0c8cb3069b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-ASSAY® Factor XIII Calibrator
• Version Model Number: KAI-106C
• Catalog Number: KAI-106C
• 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	00816426020719 [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 Calibrator]

• 00816426020764: For the calibration of the K-ASSAY® Factor XIII assay.
• 00816426020719: For the calibration of the K-ASSAY® Factor XIII assay.