AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 (00817302022117)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030
Version or Model: CC030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC030
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302022117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: FRUC (Fructosamine) Control

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?
53276	Fructosamine IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the glycated serum protein fructosamine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

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
Special Storage Condition, Specify: Opened vials are stable for 30 days when stored refrigerated at 2 to 8°C.
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Reagent is stable when stored at 2-8° C until expiration date

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Milliliter
Device Size Text, specify: Kit contains 1 control 1, 1 control 2 and 1 package insert
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: d8be70b6-8f67-4b2f-9232-7c2a4dd7e1b7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016