AccessGUDID - DEVICE: Clinistix Kidney Health Test System (00630414631707)

GUDID

Device Identifier (DI) Information

Brand Name: Clinistix Kidney Health Test System
Version or Model: 11643376
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414631707
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Test Strips for the Determination of Albumin and Creatinine in Urine

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):	No
Over the Counter (OTC):	Yes
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?
54523	Urine protein 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 protein 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
JFY	Enzymatic Method, Creatinine
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991315	000

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
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Store upright

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41504e8d-5d10-4b5e-a052-74dae4519e22
Public Version Date: May 13, 2024
Public Version Number: 1
DI Record Publish Date: May 03, 2024