Data / Medical devices / Radioimmunoassay, Luteinizing Hormone / United States
FDA-registered makers of Radioimmunoassay, Luteinizing Hormone in the United States: 26 establishments
26 establishments in the United States are registered with the FDA to make Radioimmunoassay, Luteinizing Hormone (product code CEP). 12 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Radioimmunoassay, Luteinizing Hormone
- Product code
- CEP
- Country
- United States
Makers of Radioimmunoassay, Luteinizing Hormone in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 2 | November 29, 1996 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 2 | November 29, 1996 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 2 | November 29, 1996 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | June 21, 1996 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | June 21, 1996 | 0 | 0 | 0 | api.fda.gov |
| Alfa Scientific Designs, Inc. | Poway, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | November 5, 2002 | 0 | 0 | 0 | api.fda.gov |
| Biomerica | Irvine, CA, United States | Manufacturer | 1 | July 11, 1995 | 0 | 0 | 0 | api.fda.gov |
| Church & Dwight Co., Inc. | Princeton, NJ, United States | Complaint file establishment, Specification developer | 1 | October 27, 1997 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | November 5, 2002 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | February 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Phamatech Inc. | San Diego, CA, United States | Manufacturer, Repackager or relabeler | 1 | March 22, 1999 | 0 | 0 | 0 | api.fda.gov |
| Vitrolife Inc. | San Diego, CA, United States | Manufacturer | 1 | July 27, 1987 | 0 | 0 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansh Labs, LLC | Webster, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Currier Plastics | Auburn, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eazebio | Livermore, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 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 | |
| Nypro Inc. (Chicago) | Gurnee, IL, United States | Contract 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 Inc. | Newark, DE, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer for export | 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.