Infectious diseasesBacteriology (infect. immunology/NAT)Mycobacteria genus + species
Tb-igra (interferon-gamma-release assay)
EMDN code W0105010704
Manufacturers registered in Europe (EUDAMED) 13
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Mikrogen | Germany | – 98/79 | EUDAMED record Report an error | |
| Innodx EU representative : QbD RepS BV (Belgium) | China |
|
C IVDR, 98/79 | Website EUDAMED record Report an error |
| Beijing Wantai Biological Pharmacy Enterprise EU representative : QbD RepS BV (Belgium) | China |
|
– 98/79 | EUDAMED record Report an error |
| bioMérieux FDA | France | C IVDR | EUDAMED record Report an error | |
| Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China | C IVDR | EUDAMED record Report an error | |
| Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | United States | – 98/79 | EUDAMED record Report an error | |
| Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) | China | – 98/79 | Website EUDAMED record Report an error | |
| Nano Diagnosis for Health Biotech (Guangzhou) EU representative : MedPath GmbH (Germany) | China | – 98/79 | EUDAMED record Report an error | |
| Oxford Immunotec FDA EU representative : Wallac Oy (Finland) | United Kingdom (ex Northern Ireland) | C IVDR | regulatory.oxford@revvity.com EUDAMED record Report an error | |
| Qiagen FDA | Germany | C IVDR | Website info@qiagen.com EUDAMED record Report an error | |
| Roche FDA | Germany | C IVDR | Website EUDAMED record Report an error | |
| Sichuan Orienter Biotechnology EU representative : Medunion S.L. (Spain) | China | – 98/79 | Website info@orienterglobal.com EUDAMED record Report an error | |
| Xenta Biomedical Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China | – 98/79 | Website EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
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