K-ASSAY® UIBC Reagent KAI-300

GUDID 00816426021396

For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.

KAMIYA BIOMEDICAL COMPANY, LLC

Unsaturated iron binding capacity (UIBC) IVD, reagent

• Primary Device ID: 00816426021396
• NIH Device Record Key: ac573289-03c5-4091-8ed4-dca4f0ca45ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-ASSAY® UIBC Reagent
• Version Model Number: KAI-300
• Catalog Number: KAI-300
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816426021396 [Primary]

FDA Product Code

• JMO: Ferrozine (Colorimetric) Iron Binding Capacity

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: 2019-04-17
• Device Publish Date: 2019-04-09

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• 00816426021396 - K-ASSAY® UIBC Reagent: 2019-04-17 For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.
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