CAR SLN Kit

GUDID 00858637005529

EXACT SCIENCES CORPORATION

Nucleic acid amplification mastermix kit IVD

• Primary Device ID: 00858637005529
• NIH Device Record Key: cb37e6cc-7bfd-4a10-8ecb-1743e09f1fb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAR SLN Kit
• Version Model Number: 100311
• 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	00858637005529 [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

• 00858637005833 - Reader Control v2.2: 2024-05-03 Reader Control v2.2 for Exact Sciences System Software
• 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