K-ASSAY® Plasma Control K81C-6M

GUDID 00816426020894

For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.

KAMIYA BIOMEDICAL COMPANY, LLC

Multiple coagulation factor IVD, control

• Primary Device ID: 00816426020894
• NIH Device Record Key: 4e2a4b7d-3830-4d67-94dc-9259670eba17
• Commercial Distribution Discontinuation: 2019-12-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: K-ASSAY® Plasma Control
• Version Model Number: K81C-6M
• Catalog Number: K81C-6M
• Company DUNS: 197934250
• Company Name: KAMIYA BIOMEDICAL COMPANY, LLC
• 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: 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	00816426020894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012422

FDA Product Code

• GGC: Control, Plasma, Abnormal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-27
• Device Publish Date: 2016-09-16

Devices Manufactured by KAMIYA BIOMEDICAL COMPANY, LLC

• 00816426021532 - K-ASSAY® RF Calibrator (Ver.2): 2024-04-25 For the calibration of the K-ASSAY® RF (Ver.2) assay
• 00816426021679 - K-ASSAY® hsCRP Control: 2021-03-09 For use as a consistent test sample of known concentration for monitoring assay conditions for C-reactive protein (CRP).
• 00816426021631 - K-ASSAY® Apo AI / B Control: 2021-01-05 For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
• 00816426021648 - K-ASSAY® Apo AI / B Control: 2021-01-05 For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
• 00816426020894 - K-ASSAY® Plasma Control: 2019-12-27For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
• 00816426020894 - K-ASSAY® Plasma Control: 2019-12-27 For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
• 00816426021129 - K-ASSAY® Factor XIII Control: 2019-12-27 For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.
• 00816426021396 - K-ASSAY® UIBC Reagent: 2019-04-17 For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.
• 00816426021402 - K-ASSAY® UIBC Reagent (L): 2019-04-17 For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.