Data / Medical devices / System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection / United States
FDA-registered makers of System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection (product code PHP). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Product code
- PHP
- Country
- United States
Makers of System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Exact Sciences Corporation- Discovery Campus | Madison, WI, United States | Complaint file establishment, Manufacturer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Exact Sciences Corporation- Innovation Campus | Madison, WI, United States | Manufacturer | 0 | 2 | 1 | 0 | api.fda.gov | |
| Exact Sciences Corporation- Legacy Campus | Madison, WI, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| GUARDANT HEALTH, INC (Campus) | Redwood City, CA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| New Day Diagnostics | Knoxville, TN, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Molex Little Rock | Maumelle, AR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips-Medisize, LLC | New Richmond, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sigma-Aldrich Manufacturing, LLC | St. Louis, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VWR Chemicals, LLC | Solon, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.