Data / Medical devices / Radioimmunoassay, Tricyclic Antidepressant Drugs / United States
FDA-registered makers of Radioimmunoassay, Tricyclic Antidepressant Drugs in the United States: 21 establishments
21 establishments in the United States are registered with the FDA to make Radioimmunoassay, Tricyclic Antidepressant Drugs (product code LFG). 11 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Radioimmunoassay, Tricyclic Antidepressant Drugs
- Product code
- LFG
- Country
- United States
Makers of Radioimmunoassay, Tricyclic Antidepressant Drugs in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 2 | August 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Ucp Biosciences, Inc. | Milpitas, CA, United States | Specification developer | 2 | September 20, 2007 | 0 | 0 | 0 | api.fda.gov |
| Alere San Diego, Inc. | San Diego, CA, United States | Specification developer | 1 | July 17, 2002 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Specification developer | 1 | July 17, 2002 | 0 | 0 | 0 | api.fda.gov |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 1 | August 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Manufacturer | 1 | June 8, 2001 | 0 | 0 | 0 | api.fda.gov |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Manufacturer | 1 | June 8, 2001 | 0 | 0 | 0 | api.fda.gov |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 1 | March 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 1 | March 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 1 | March 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | July 2, 1982 | 0 | 0 | 0 | api.fda.gov |
| ABOUND Diagnostics, Inc | San Diego, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advin Biotech, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alfa Scientific Designs, Inc. | Poway, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Calbiotech, Inc. | El Cajon, CA, United States | Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chemtron Biotech, Inc. | San Diego, CA, United States | Complaint file establishment, Contract manufacturer, 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 | |
| Medical Disposables Corp | Orlando, FL, United States | Complaint file establishment, Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quidel Cardiovascular Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| W.H.P.M., Inc. | Irwindale, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.