Sirrus® Total Iron LiquiColor® S0370-600

GUDID 00657498001530

For the Quantitative Colorimetric Determination of Iron in Serum.

STANBIO LABORATORY, L.P.

Total iron binding capacity (TIBC) IVD, kit, spectrophotometry Total iron binding capacity (TIBC) IVD, kit, spectrophotometry

• Primary Device ID: 00657498001530
• NIH Device Record Key: 12d4b5c4-c7de-4e10-ab6f-83af2e951318
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sirrus® Total Iron LiquiColor®
• Version Model Number: S0370-600
• Catalog Number: S0370-600
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• 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: false
• Device Combination Product: false
• Single Use: true
• 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: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498001530 [Primary]

FDA Product Code

• JIY: Photometric Method, Iron (Non-Heme)

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: 2018-04-16
• Device Publish Date: 2016-09-23

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