Reese's ColoTest

GUDID 10023513132157

REESE PHARMACEUTICAL COMPANY

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• Primary Device ID: 10023513132157
• NIH Device Record Key: 667f0b20-13bd-4445-a095-6275c5dc8e1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reese's ColoTest
• Version Model Number: 05-7632RS-2
• 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: 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	10023513132157 [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: 2024-05-06
• Device Publish Date: 2024-04-26