Data / Medical devices / Radioimmunoassay, 17-Hydroxyprogesterone
Radioimmunoassay, 17-Hydroxyprogesterone (JLX): 14 FDA-registered makers in 7 countries
14 establishments in 7 countries are registered with the FDA to make Radioimmunoassay, 17-Hydroxyprogesterone (product code JLX, Class 1, 21 CFR 862.1395). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on July 23, 2010, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JLX
- Device class
- 1
- Regulation
- 862.1395
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Germany | 4 |
| Finland | 1 |
| Canada | 1 |
| China | 1 |
| Belgium | 1 |
| Japan | 1 |
Makers of Radioimmunoassay, 17-Hydroxyprogesterone
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 |
|---|---|---|---|---|---|---|---|---|
| Wallac OY | TURKU Varsinais-Suomi, Finland | Complaint file establishment, Manufacturer | 2 | July 23, 2010 | 0 | 0 | 0 | api.fda.gov |
| Astoria-Pacific, Inc. | Clackamas, OR, United States | Complaint file establishment, Manufacturer | 1 | March 13, 2007 | 0 | 0 | 0 | api.fda.gov |
| DEMEDITEC DIAGNOSTICS GmbH | KIEL-WELLSEE Schleswig-Holstein, Germany | Manufacturer, Repackager or relabeler | 1 | January 29, 2008 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 1 | January 29, 2008 | 0 | 0 | 0 | api.fda.gov |
| Diagnostics Biochem Canada, Inc. | London Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSource ImmunoAssays, SA | Louvain-La-Neuve Brabant Wallon, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ibl International GMBH | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 23, 2010. 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.