Data / Medical devices / United States / Exact Sciences Corporation- Innovation Campus
Exact Sciences Corporation- Innovation Campus: FDA-registered device maker in Madison, WI, United States, 2 PMA approvals
Exact Sciences Corporation- Innovation Campus is registered with the FDA (registration 3008256118) in Madison, WI, United States. It lists 5 device types. The FDA files 2 PMA approvals under its listings, the newest dated October 3, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008256118
- Address
- 441 Charmany Dr, Madison, WI, United States, 53719
- Owner or operator
- Exact Sciences Corporation (10047364)
- Roles
- Manufacturer
- First device listed
- August 18, 2014
- Registered through
- 2026
- Brand names listed
- Capture Aspirator, Capture Incubator, Capture Incubator 2, Cologuard, Cologuard Plus, Conversion Wash 2 (Concentrate), Sample Mixer, Sample Mixer 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bath, Incubators/Water, All | JTQ | 1 | Manufacturer | accessdata.fda.gov |
| Blender/Mixer | JRO | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | Manufacturer | accessdata.fda.gov |
| System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | PHP | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 3, 2024 | P230043 | Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus | PHP | 10 | August 3, 2026 | accessdata.fda.gov |
| August 11, 2014 | P130017 | COLOGUARD | PHP | 69 | June 9, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 28, 2017 | 77260 | Class II | Terminated | Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic t | Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door. | accessdata.fda.gov |
Compare with other makers
- All makers of Blender/Mixer
- All makers of Bath, Incubators/Water, All
- All makers of System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- All makers of General Purpose Reagent
- All makers of Station, Pipetting And Diluting, For Clinical Use
Updated August 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.