AccessGUDID - DEVICE: Kidney Health Test Kit 3 (00860013969523)

GUDID

Device Identifier (DI) Information

Brand Name: Kidney Health Test Kit 3
Version or Model: uACR01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ditek Consulting, LLC

Primary DI Number: 00860013969523
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111296701 *Terms of Use

Device Description: These kits are designed to detect early signs of kidney damage or disease by analyzing your urine, blood, or both.

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):	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?
18026	Phlebotomy kit	A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 33109509-8646-4035-bab8-f2f7c4cf4274
Public Version Date: May 14, 2025
Public Version Number: 1
DI Record Publish Date: May 06, 2025