UIBC-SL

Basic Information

• Brand Name: UIBC-SL
• Primary DI: 00628063400928
• Version / Model: 153-10
• Catalog Number: 153-10
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Labeler DUNS: 966812344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e1506335-9709-411c-942a-df11990e29cd

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JMO	Ferrozine (colorimetric) iron binding capacity	Clinical Chemistry	862.1415	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58196	Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of unsaturated iron binding capacity (UIBC) of a clinical specimen, using a spectrophotometry method. UIBC is typically determined by measuring the available capacity of the transport protein transferrin to bind free iron.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628063400928	GS1

Premarket Submissions

Submission Number	Supplement Number
K963116	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius