Infectious diseasesOther virology tests (infect. immunology/NAT)Epstein barr virus
Ebv antibodies
EMDN code W0105040401
Manufacturers registered in Europe (EUDAMED) 26
- 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) 13
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 |
|---|---|---|---|
| Bio-Rad Present in Europe in other categories | United States | BioPlex 2200 Bio-Rad Laboratories Bio-Rad | K062211 (2006) |
| CLARK LABORATORIES, INC. | United States | Trinity Biotech Bio-Rad Platelia Platelia | K980596 (1998) |
| Quest Intl., Inc. | United States | ReQuest SeraQuest | K091260 (2009) |
| Diamedix Corp. | United States | Diamedix | K981812 (1999) |
| ARLINGTON SCIENTIFIC, INC. | United States | ASI EB VCA IgG EIA Test ASI EBNA IgG EIA Test | registered |
| SCIMEDX CORPORATION | – | EBV EA 10 Well; 10 pk EBV-EA IgG 120 Test Kit | registered |
| BIOCHECK, INC. | United States | – | registered |
| Biokit, S.A. Present in Europe in other categories | Spain | – | K233606 (2024) |
| Calbiotech, Inc. | United States | – | registered |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Immuno Concepts, Inc. Present in Europe in other categories | United States | – | K912488 (1991) |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | – | K260221 (2026) |
| Zeus Scientific, Inc. Present in Europe in other categories | United States | – | K983801 (1998) |
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