Data / Medical devices / Reagent, Borrelia Serological Reagent / Germany
FDA-registered makers of Reagent, Borrelia Serological Reagent in Germany: 5 establishments
5 establishments in Germany are registered with the FDA to make Reagent, Borrelia Serological Reagent (product code LSR). 4 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
- Reagent, Borrelia Serological Reagent
- Product code
- LSR
- Country
- Germany
Makers of Reagent, Borrelia Serological Reagent in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Viramed Biotech AG | PLANEGG Bavaria, Germany | Manufacturer | 5 | August 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 3 | May 2, 1990 | 0 | 0 | 0 | api.fda.gov |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 3 | December 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 3 | December 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| Gold Standard Diagnostics Frankfurt GmbH | Dietzenbach Hesse, Germany | 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.