K-ASSAY® Prealbumin Reagent KAI-053

GUDID 00816426020276

For the quantitative determination of human prealbumin in serum by immunoturbidimetric assay.

KAMIYA BIOMEDICAL COMPANY, LLC

Prealbumin (transthyretin) IVD, reagent

• Primary Device ID: 00816426020276
• NIH Device Record Key: 92c16e5c-7e5e-444a-a7d6-e8d575eeede7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-ASSAY® Prealbumin Reagent
• Version Model Number: KAI-053
• Catalog Number: KAI-053
• 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	00816426020276 [Primary]

FDA Product Code

• JZJ: Prealbumin, 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

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