ReagentsInfectious diseasesBacteriology (infect. immunology/NAT)
Lyme borreliosis
EMDN code W01050106
Manufacturers registered in Europe (EUDAMED) 33
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 22
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| MARDX DIAGNOSTICS, INC. | United States | Trinity Biotech | K951709 (1996) |
| Bio-Rad Present in Europe in other categories | United States | BioPlex 2200 Bio-Rad Laboratories, Inc. | K183446 (2019) |
| CLARK LABORATORIES, INC. | United States | MarDx Trinity Biotech | registered |
| IMMCO DIAGNOSTICS, INC. | United States | Immco Diagnostics, Inc. | registered |
| Bion Enterprises, Ltd. | United States | Borrelia IgM Control Borrelia IgG Control Borrelia Negative Control | registered |
| DRG Instruments Gesellschaft mit beschränkter Haftung | – | Borrelia burgdorferi IgG (Lyme) ELISA B. burgdorferi IgG/IgM ELISA Borrelia burgdorferi IgM (Lyme) ELISA | registered |
| DRG International Inc | United States | B. burgdorferi IgG/IgM ELISA Borrelia burgdorferi IgG (Lyme) ELISA Borrelia burgdorferi IgM (Lyme) ELISA | registered |
| Diagnostic Automation, Inc. | – | AccuDiag ™ QMedix™ | registered |
| Lgc Clinical Diagnostics, Inc. Present in Europe in other categories | United States | ACCURUN® | registered |
| Quidel Corp. | United States | Sofia | K173496 (2018) |
| Zeus Scientific, Inc. Present in Europe in other categories | United States | ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System Anti-Borrelia VlsE1/pepC10 IgG/IgM | K230863 (2023) |
| Immunetics, Inc. | United States | C6 B. burgdorferi (Lyme) ELISA | K003754 (2001) |
| BIOCHECK, INC. | United States | – | registered |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| GenDx LLC Present in Europe in other categories | United States | – | registered |
| Id-Fish Technology, Inc. | United States | – | K242872 (2025) |
| Inanovate, Inc. | United States | – | K252627 (2025) |
| Ortho Clinical Diagnostics Inc. (QuidelOrtho) Present in Europe in other categories | United States | – | K254295 (2026) |
| QuidelOrtho Corporation | United States | – | registered |
| Scantibodies Laboratory Inc. | United States | – | registered |
| Trinity Biotech USA Present in Europe in other categories | United States | – | K172254 (2017) |
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