| Primary Device ID | 00858637005536 |
| NIH Device Record Key | d4dea269-96b7-4641-a2b8-a3fb00cacda0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELU BFR Kit |
| Version Model Number | 100312 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00858637005536 [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 | 2021-09-06 |
| Device Publish Date | 2021-08-27 |
| 00858637005840 - Analysis Server v2.2 | 2025-03-27 Exact Sciences Software System 2.2 |
| 00858637005857 - Analysis Client v2.2 | 2025-03-27 Exact Sciences Software System 2.2 |
| 00858637005864 - STARlet Interface v2.2 | 2025-03-27 Exact Sciences Software System 2.2 |
| 00858637005871 - Cycler Control v2.2 | 2025-03-27 Exact Sciences Software System 2.2 |
| 00858637005888 - Cologuard Test Definition v1.7 | 2025-03-27 |
| 00858637005901 - Cologuard 2 Test Definition | 2025-03-27 |
| 00858637005949 - The Cologuard Plus Collection Kit | 2025-03-27 |
| 00850057859003 - CG2 CAP BDS | 2025-02-27 Magnetic particles with covalently bound oligonucleotide probes (400 mL x 20 ea) |