FDA Registration
Active
🇺🇸 United States
Exact Sciences Corporation- Innovation Campus
Reg #: 3008256118
·
FEI: 3008256118
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Exact Sciences Corporation- Innovation Campus
- Registration Number
- 3008256118
- FEI Number
- 3008256118
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 441 Charmany Dr
- City
- Madison
- State
- WI
- ZIP
- 53719
- Country
- US
Regulatory Submissions
- PMA Number
- P230043
Owner / Operator
- Firm Name
- Exact Sciences Corporation
- Operator Number
- 10047364
- Address
- 5505 Endeavor Lane
- City
- Madison
- State
- WI
- Postal Code
- 53719
- Country
- US
- Correspondent
- Ashlie Rodriguez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2024-07-16 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2017-07-12 |
| System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | PHP | Class 3 | Unknown | No | 2025-02-12 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2017-02-08 |
| Blender/Mixer | JRO | Class 1 | Clinical Chemistry | No | 2014-08-18 |
Proprietary Names
Conversion Wash 2 (Concentrate)
Capture Aspirator
Cologuard Plus
Cologuard
Capture Incubator 2
Capture Incubator
Sample Mixer
Sample Mixer 2
Establishment Types
Manufacture Medical Device