AccessGUDID - DEVICE: GENCHEM™ Creatinine Test Reagent (00851445007174)

GUDID

Device Identifier (DI) Information

Brand Name: GENCHEM™ Creatinine Test Reagent
Version or Model: GEN-CREA R1(Base)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GEN-CREA R1(Base)
Company Name: GENCHEM INC

Primary DI Number: 00851445007174
Issuing Agency: GS1
Commercial Distribution End Date: August 19, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 193856866 *Terms of Use

Device Description: 10/17/2022

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
53249	Creatine IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of creatine 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 25b8db84-04dd-4bea-b57b-a325ea07eba9
Public Version Date: October 21, 2022
Public Version Number: 4
DI Record Publish Date: September 19, 2016