K-ASSAY® Total IgE Control K94C-4M

GUDID 00816426021389

For use as a consistent test sample of known concentration for monitoring assay conditions for Total IgE.

KAMIYA BIOMEDICAL COMPANY, LLC

Total immunoglobulin E (IgE total) IVD, control Total immunoglobulin E (IgE total) IVD, control Total immunoglobulin E (IgE total) IVD, control

• Primary Device ID: 00816426021389
• NIH Device Record Key: c06b824c-d414-4417-ba7a-ef3c13342c09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-ASSAY® Total IgE Control
• Version Model Number: K94C-4M
• Catalog Number: K94C-4M
• 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	00816426021389 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-25
• Device Publish Date: 2019-01-25

On-Brand Devices [K-ASSAY® Total IgE Control]

• 00816426021389: For use as a consistent test sample of known concentration for monitoring assay conditions for T
• 00816426021372: For use as a consistent test sample of known concentration for monitoring assay conditions for T