AccessGUDID - DEVICE: Creatinine Reagent Set (00812137011961)

GUDID

Device Identifier (DI) Information

Brand Name: Creatinine Reagent Set
Version or Model: R1 x 500mL, R2 x 125mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 501-409
Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Primary DI Number: 00812137011961
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 048144997 *Terms of Use

Device Description: For the quantitative determination of creatinine in serum. For in vitro diagnostic use only. Creatinine assays are most frequently performed to aid in the determination of renal function.

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):	No
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?
53252	Creatinine IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.	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: 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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 17db1303-4daa-4f77-a571-97e6ea798f83
Public Version Date: December 20, 2022
Public Version Number: 3
DI Record Publish Date: October 12, 2016