CONJ Kit

GUDID 00858637005642

EXACT SCIENCES CORPORATION

Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent

• Primary Device ID: 00858637005642
• NIH Device Record Key: 996e790a-c367-44e7-828e-34044ef1d6e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONJ Kit
• Version Model Number: 100323
• 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: true
• 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	00858637005642 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-06
• Device Publish Date: 2021-08-27

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