| Primary Device ID | 00858637005048 |
| NIH Device Record Key | c232bd53-a78c-4bbd-b541-efa70cf71206 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cologuard QuARTS Assay Reagents |
| Version Model Number | 100030 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00858637005048 [Primary] |
| PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-11-17 |
| 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 |