AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.™ FRUC FRUCTOSAMINE CC612 (00817302022131)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.™ FRUC FRUCTOSAMINE CC612
Version or Model: CC612
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC612
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302022131
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: FRUC (Fructosamine) w/ cal 2 x 40 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?
53274	Fructosamine IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the glycated serum protein fructosamine in a clinical specimen, using a spectrophotometry method. It is typically used to aid in monitoring of average glucose levels and glycaemic control in diabetic patients.	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: Reagent is stable on board a clinical analyzer for 15 days
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
Device Size Text, specify: Kit contains 2 Buffer bottles, 1 calibrator bottle, 2 empty reagent cartridges, 1 package insert and 2 user defined parameters
Total Volume: 2 Milliliter
Total Volume: 11 Milliliter

Device Record Status

Public Device Record Key: 4d47ac37-57ab-47cd-9fac-6f2a66d0a1ca
Public Version Date: February 16, 2024
Public Version Number: 4
DI Record Publish Date: September 01, 2016