K-ASSAY® Lp(a) Control K114C-4M

GUDID 00816426020979

For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)].

KAMIYA BIOMEDICAL COMPANY, LLC

Total lipoprotein IVD, control Total lipoprotein IVD, control Total lipoprotein IVD, control

• Primary Device ID: 00816426020979
• NIH Device Record Key: c29e435a-9b57-49f0-a993-515ee73a143e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-ASSAY® Lp(a) Control
• Version Model Number: K114C-4M
• Catalog Number: K114C-4M
• 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	00816426020979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023853

FDA Product Code

• DFC: Lipoprotein, Low-Density, 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: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [K-ASSAY® Lp(a) Control]

• 00816426020979: For use as a consistent test sample of known concentration for monitoring assay conditions for l
• 00816426020962: For use as a consistent test sample of known concentration for monitoring assay conditions for l