AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® PH REAGENT REAGENT KIT CC447 (00817302024319)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® PH REAGENT REAGENT KIT CC447
Version or Model: CC447
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC447
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302024319
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: PH REAGENT

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?
54522	Urine pH 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 to determine pH 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
JQY	pH meter

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 2 R1 bottles
Total Volume: 500 Milliliter

Device Record Status

Public Device Record Key: f7e5083b-8916-404c-98a3-7ca4975518c6
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: August 19, 2022