Data / Medical devices / System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection (PHP): 10 FDA-registered makers in 2 countries
10 establishments in 2 countries are registered with the FDA to make System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection (product code PHP, Class 3). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PHP
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Italy | 1 |
Makers of System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 | |
| Sentinel CH. SPA | Milano, Italy | 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.