ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyTissue typing reagents
Hla antigen typing
EMDN code W01030403
Manufacturers registered in Europe (EUDAMED) 4
- 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) 3
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 |
|---|---|---|---|
| Genbio | United States | GenDx-LongMix NGSgo®-AmpX v2 HLA-B (96) NGS-Turbo® demo workflow reagents KMRtrack Monitoring marker KMR034 (48) NGSgo®-AmpX v3 HLA-B (96) KMRtrack Monitoring marker KMR050 (48) | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | – | registered |
| Genome Diagnostics Sweden AB | Sweden | – | registered |
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