Color Stool Collection Kit

GUDID 00860014139338

Color Diagnostics, LLC

Faecal occult blood IVD, reagent

• Primary Device ID: 00860014139338
• NIH Device Record Key: 66535c40-0b9b-4ea2-be0b-ea756fe6f35e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Color Stool Collection Kit
• Version Model Number: 1.0
• Company DUNS: 118772507
• Company Name: Color Diagnostics, 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	00860014139338 [Primary]

FDA Product Code

• OOX: Automated Occult Blood Analyzer

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: 2025-06-17
• Device Publish Date: 2025-06-09

Devices Manufactured by Color Diagnostics, LLC

• 00860014139307 - Color Saliva Collection Kit: 2025-06-17
• 00860014139314 - Color Urine Collection Kit: 2025-06-17
• 00860014139321 - Color Blood Collection Kit (Upper Arm): 2025-06-17
• 00860014139338 - Color Stool Collection Kit: 2025-06-17
• 00860014139338 - Color Stool Collection Kit: 2025-06-17