AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® UIBC UNSATURATED IRON BINDING CAPACITY CC660 (00817302022704)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® UIBC UNSATURATED IRON BINDING CAPACITY CC660
Version or Model: CC660
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC660
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302022704
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JMO	Ferrozine (colorimetric) iron binding capacity
JIS	CALIBRATOR, PRIMARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type 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

Device Record Status

Public Device Record Key: 65cfff15-2a53-4555-b5eb-2ab528883e90
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 12, 2016