Data / Medical devices / Reagent, Borrelia Serological Reagent / United States
FDA-registered makers of Reagent, Borrelia Serological Reagent in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Reagent, Borrelia Serological Reagent (product code LSR). 14 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Reagent, Borrelia Serological Reagent
- Product code
- LSR
- Country
- United States
Makers of Reagent, Borrelia Serological Reagent in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gold Standard Diagnostics, LLC | Davis, CA, United States | Repackager or relabeler, Specification developer | 8 | March 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 5 | July 26, 2012 | 0 | 0 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 4 | February 18, 2021 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Repackager or relabeler | 4 | May 2, 1990 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 4 | November 26, 2003 | 0 | 0 | 0 | api.fda.gov |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 2 | October 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Specification developer | 2 | August 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 2 | August 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Quidel Corp. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 2 | August 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer, Specification developer | 1 | December 20, 1991 | 0 | 0 | 0 | api.fda.gov |
| Bion Enterprises, Ltd. | Des Plaines, IL, United States | Contract manufacturer, Manufacturer | 1 | April 5, 1990 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 1 | March 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| Genbio | San Diego, CA, United States | Manufacturer | 1 | December 20, 1991 | 0 | 1 | 0 | api.fda.gov |
| Inanovate Inc | Sioux Falls, SD, United States | Manufacturer | 1 | November 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scantibodies Laboratory, Inc. | Santee, CA, United States | Contract manufacturer | 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.