| Primary Device ID | 00858637005826 |
| NIH Device Record Key | 14eb3c34-05a5-47e8-853e-8d4d9c89dc02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cologuard Test Definition v1.6 |
| Version Model Number | 1.6 |
| 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 | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858637005826 [Primary] |
| PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-08 |
| Device Publish Date | 2021-05-31 |
| 00858637005345 - CAP SLN | 2024-11-28 |
| 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 |