CAROLINA LIQUID CHEMISTRIES CORP.® UIBC UNSATURATED IRON BINDING CAPACITY CC660

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® UIBC UNSATURATED IRON BINDING CAPACITY CC660
• Primary DI: 00817302022704
• Version / Model: CC660
• Catalog Number: CC660
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 65cfff15-2a53-4555-b5eb-2ab528883e90

Device Description

UIBC (Unsaturated Iron Binding Capacity) w/ cal 2 x 100 tests

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
JIS	CALIBRATOR, PRIMARY	Clinical Chemistry	862.1150	2

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	00817302022704	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	32	Milliliter
Total Volume	8	Milliliter
Device Size Text, specify			Kit contains 2 filled reagent cartridges, 1 filled UIBC Calibrator bottle, 2 UIBC User Defined Parameters, 1 UIBC Calibrator package insert, and 1 UIBC reagent package insert
Total Volume	10	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Reagent is stable until expiration date when store at 2-8°C and protected from light.