AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE CHECK REAGENT KIT CC448 (00817302024326)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE CHECK REAGENT KIT CC448
Version or Model: CC448
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC448
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302024326
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: CREATININE CHECK

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:	No
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?
54517	Urine creatinine IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for creatinine within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGX	ALKALINE PICRATE, COLORIMETRY, CREATININE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 8 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 1 R1 bottle and 1 R2 bottle
Total Volume: 500 Milliliter

Device Record Status

Public Device Record Key: 0e9af76e-4e65-4746-b4e9-0a5cdcab5edb
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: August 19, 2022