ReagentsInfectious diseasesOther virology tests (infect. immunology/NAT)
Rubella virus
EMDN code W01050401
Manufacturers registered in Europe (EUDAMED) 27
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
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 |
|---|---|---|---|
| CLARK LABORATORIES, INC. | United States | Trinity Biotech | K921573 (1992) |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | Elecsys Rubella IgM Elecsys Rubella IgG Immunoassay Elecsys Rubella IgG Elecsys Rubella IgM Immunoassay | K092322 (2010) |
| MONOBIND, INC. Present in Europe in other categories | United States | Rubella IgG AccuBind ELISA Test System - 192 Wells Rubella IgM AccuBind ELISA Test System - 96 Wells Rubella IgG AccuBind ELISA Test System - 96 Wells Rubella IgM AccuBind ELISA Test System - 192 Wells | registered |
| Quest Intl., Inc. | United States | ReQuest SeraQuest | K982281 (1998) |
| Diamedix Corp. | United States | Diamedix | K093101 (2011) |
| ARLINGTON SCIENTIFIC, INC. | United States | ASI Rubella IgG EIA Test ASI Rubella IgM EIA Test | registered |
| Bio-Rad Present in Europe in other categories | United States | Bio-Rad Laboratories, Inc. | K092587 (2010) |
| Diagnostic Automation, Inc. | – | AccuDiag ™ | registered |
| HORIBA INSTRUMENTS INCORPORATED | United States | Pointe Scientific, Inc. Rubella IgM Pointe Scientific, Inc. Rubella IgG | registered |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | K063143 (2006) |
| Princeton BioMeditech Corp. Present in Europe in other categories | United States | BioSign® Rubella card | registered |
| ALERE NORTH AMERICA, LLC | – | Alere Rubella-plus® | registered |
| Abbott Diagnostics Present in Europe in other categories | United States | Alinity | registered |
| Abbott Laboratories Present in Europe in other categories | United States | – | K243168 (2025) |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| SST International Inc. | United States | – | registered |
| Tosoh Bioscience, Inc. | United States | – | registered |
| Trinity Biotech USA Present in Europe in other categories | United States | – | registered |
| Zeus Scientific, Inc. Present in Europe in other categories | United States | – | K063186 (2007) |
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