Reese's ColoTest

GUDID 10023513132140

REESE PHARMACEUTICAL COMPANY

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• Primary Device ID: 10023513132140
• NIH Device Record Key: f09c65ae-3bdd-441e-85be-d9728530426c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reese's ColoTest
• Version Model Number: 05-7632RS
• Company DUNS: 004172052
• Company Name: REESE PHARMACEUTICAL COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	10023513132140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173212

FDA Product Code

• KHE: Reagent, Occult Blood

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: 2024-01-31
• Device Publish Date: 2024-01-23