Data / Medical devices / System, Test, Carcinoembryonic Antigen
System, Test, Carcinoembryonic Antigen (DHX): 16 FDA-registered makers in 6 countries
16 establishments in 6 countries are registered with the FDA to make System, Test, Carcinoembryonic Antigen (product code DHX, Class 2, 21 CFR 866.6010). 10 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on September 22, 2023, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DHX
- Device class
- 2
- Regulation
- 866.6010
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| United Kingdom | 2 |
| Ireland | 2 |
| Japan | 1 |
| Germany | 1 |
| France | 1 |
Makers of System, Test, Carcinoembryonic Antigen
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 3 | April 13, 2020 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Specification developer | 2 | September 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 2 | August 23, 2023 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 2 | August 23, 2023 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 2 | April 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 2 | December 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| Abbott Ireland | Sligo, Ireland | Manufacturer | 1 | May 11, 1999 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | June 29, 1998 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | June 25, 2008 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | April 21, 1998 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad | STEENVOORDE Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 22, 2023. 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.