UIBC SI250

GUDID 05055273206180

The product is intended for the quantitative in vitro determination of Iron/UIBC in serum.

RANDOX LABORATORIES LIMITED

Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry

• Primary Device ID: 05055273206180
• NIH Device Record Key: 23bd03c6-27d3-4d47-a98f-81d3dc7526fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UIBC
• Version Model Number: SI250
• Catalog Number: SI250
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• 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: 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: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *R2. Stable for 4 weeks at +2 to +8°C. R4. Stable for 6 months at +15 to +25°C. All other reagents are ready for use as supplied. Stable to expiry date when stored at +15 to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273206180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974604

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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