FDA device listing
Cologuard
FDA device listing 1648519065 · Exact Sciences Corporation
Key facts
| Proprietary names | Cologuard |
|---|---|
| Owner/operator | Exact Sciences Corporation |
| Owner/operator number | 10047364 |
| Premarket submissions | P130017 |
| Product codes | PHP |
| Device names | PHP - System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.PHP |
| Review panels | Pathology |
| Registered establishments | Exact Sciences Corporation- Discovery Campus, Exact Sciences Corporation- Innovation Campus, Exact Sciences Corporation- Legacy Campus |
| Establishment registrations | 3008256118, 3013841562, 3015728010 |
| FEI numbers | 3008256118, 3013841562, 3015728010 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database