Kidney Health Test Kit 3

Basic Information

• Brand Name: Kidney Health Test Kit 3
• Primary DI: 00860013969523
• Version / Model: uACR01
• Company Name: Ditek Consulting, LLC
• Labeler DUNS: 111296701
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-06
• Public Version: 1
• Public Version Date: 2025-05-14
• Public Version Status: New
• Public Device Record Key: 33109509-8646-4035-bab8-f2f7c4cf4274

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013969523	GS1