Data / Medical devices / Enzyme Linked Immunoabsorption Assay, Treponema Pallidum / United States
FDA-registered makers of Enzyme Linked Immunoabsorption Assay, Treponema Pallidum in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP). 11 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
- Product code
- LIP
- Country
- United States
Makers of Enzyme Linked Immunoabsorption Assay, Treponema Pallidum in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 2 | February 10, 2011 | 0 | 0 | 0 | api.fda.gov |
| Arlington Scientific, Inc. | Springville, UT, United States | Manufacturer, Repackager or relabeler | 1 | August 10, 2006 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Specification developer | 1 | September 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 1 | May 11, 2017 | 0 | 1 | 0 | api.fda.gov |
| Diagnostics Direct LLC | Stone Harbor, NJ, United States | Manufacturer | 1 | August 1, 2011 | 0 | 0 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 1 | July 31, 2006 | 0 | 1 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Repackager or relabeler | 1 | November 29, 2000 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | August 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | January 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | January 20, 2012 | 0 | 2 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer, Manufacturer for export | 1 | January 24, 2002 | 0 | 2 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chembio Diagnostic Systems, Inc. | Medford, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chembio Diagnostic Systems | Bay Shore, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 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 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.