Data / Medical devices / Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Kit, Test,Alpha-Fetoprotein For Testicular Cancer (LOJ): 14 FDA-registered makers in 4 countries
14 establishments in 4 countries are registered with the FDA to make Kit, Test,Alpha-Fetoprotein For Testicular Cancer (product code LOJ, Class 2, 21 CFR 866.6010). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on September 15, 2022, and lists 7 recall events (0 Class I). FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- LOJ
- Device class
- 2
- Regulation
- 866.6010
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| United Kingdom | 2 |
| Germany | 1 |
| Japan | 1 |
Makers of Kit, Test,Alpha-Fetoprotein For Testicular Cancer
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 |
|---|---|---|---|---|---|---|---|---|
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 2 | September 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | June 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 1 | June 15, 2022 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | April 27, 2009 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | March 27, 2002 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | March 27, 2002 | 0 | 0 | 0 | api.fda.gov |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 1 | December 17, 2002 | 0 | 0 | 0 | api.fda.gov |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 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 Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victorch Meditek, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 15, 2022. 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.