| Primary Device ID | 00858637005000 |
| NIH Device Record Key | 47bfacd7-64d3-49fc-a101-f8a2ea1facb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cologuard DNA Capture Reagents |
| Version Model Number | 100028 |
| 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 | 00858637005000 [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 |
| 00850057859003 - CG2 CAP BDS | 2025-02-27 Magnetic particles with covalently bound oligonucleotide probes (400 mL x 20 ea) |
| 00850057859010 - CG2 CAP WSH | 2025-02-27 MOPS Buffer, NaCl (20L) |
| 00850057859027 - CG2 BND SLN | 2025-02-27 Binding Solution, Guanidine Hydrochloride, Citric Acid, Sodium Citrate Tribase Dihydrate (10 L) |
| 00850057859034 - CG2 REC BFR | 2025-02-27 Reconstitution Buffer, 10% Albumin in Tris buffered solution, antimicrobial agent (800 mL) |
| 00858637005918 - CG2 CNV WSH | 2025-02-27 Conversion Wash (Concentrate), Tris Buffer, Sodium Azide ( 900 mL) |
| 00858637005925 - CG2 WSH | 2025-02-27 Hb Bead Based Assay Wash, Phosphate Buffer with Detergent (800 mL) |
| 00858637005963 - DNA and LQAS Reagent SLIB Group Kit | 2025-02-27 |
| 00858637005970 - DNA Controls SLIB Group Kit | 2025-02-27 |