Cologuard DNA Preparation Reagent

GUDID 00858637005031

EXACT SCIENCES CORPORATION

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 00858637005031
• NIH Device Record Key: 54d454b7-0acb-46fa-a88b-71f985a06e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cologuard DNA Preparation Reagent
• Version Model Number: 100029
• Company DUNS: 150908853
• Company Name: EXACT SCIENCES CORPORATION
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858637005031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130017

FDA Product Code

• PHP: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-17

Devices Manufactured by EXACT SCIENCES CORPORATION

• 00858637005338 - Cologuard STL BFR: 2024-02-02 Stool Buffer, 1000 L
• 00858637005932 - Cologuard FILT: 2024-02-02 Spin Filter, 300 ea
• 00858637005420 - D CTRL 1 Kit: 2021-09-06
• 00858637005437 - D CTRL 2 Kit: 2021-09-06
• 00858637005444 - D CTRL 3 Kit: 2021-09-06
• 00858637005451 - D CAL 1 Kit: 2021-09-06
• 00858637005468 - D CAL 2 Kit: 2021-09-06
• 00858637005475 - D CAL 3 Kit: 2021-09-06