Kidney Health Test Kit 3

GUDID 00860013969523

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

Ditek Consulting, LLC

Phlebotomy kit

• Primary Device ID: 00860013969523
• NIH Device Record Key: 33109509-8646-4035-bab8-f2f7c4cf4274
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kidney Health Test Kit 3
• Version Model Number: uACR01
• Company DUNS: 111296701
• Company Name: Ditek Consulting, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013969523 [Primary]

FDA Product Code

• OIB: Blood And Urine Collection Kit (Excludes Hiv Testing)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-14
• Device Publish Date: 2025-05-06

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