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Infectious diseasesControls/standards/calibrators - (infect. immunology/NAT)Controls - infect. immunology

Controls - inf. immunology - other

EMDN code W0105080899

23 manufacturers, 71 models including 71 on the market, 10 countries

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Manufacturers registered in Europe (EUDAMED) 23
  • 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.
ManufacturerCountryRegistered modelsClassContact
Biomaxima Poland
9 others
 B IVDR Website info@biomaxima.com EUDAMED record Report an error
LGC Clinical Diagnostics FDA EU representative : MediMark Europe Sarl. (France) United States
3 others
 B IVDR, 98/79 EUDAMED record Report an error
Techno-path Manufacturing FDA Ireland
1 other
 – 98/79 Website EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) United States – 98/79 Website EUDAMED record Report an error
Maccura EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China B IVDR, 98/79 Website EUDAMED record Report an error
DiaMex Germany – 98/79 Website EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States – 98/79 Website contact@siemens-healthineers.com EUDAMED record Report an error
Abbott FDA EU representative : Emergo Europe B.V. (Netherlands) United States – 98/79 Website EUDAMED record Report an error
Euroimmun FDA Germany – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Certest Spain – 98/79 Website quality@certest.es EUDAMED record Report an error
Chronolab Spain – 98/79 Website info@chronolab.com EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States – 98/79 Website ivdr_dsm@diasorin.com EUDAMED record Report an error
Microbiologics FDA EU representative : MediMark Europe Sarl. (France) United States B IVDR Website info@microbiologics.com EUDAMED record Report an error
Randox FDA Northern Ireland B IVDR Website EUDAMED record Report an error
altona Diagnostics FDA Germany B IVDR info@altona-diagnostics.com EUDAMED record Report an error
Biologicals Quality Control Netherlands B IVDR Website info@bioqcontrol.com EUDAMED record Report an error
Hain Lifescience Germany A IVDR EUDAMED record Report an error
Invitrosco EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website EUDAMED record Report an error
Otsukael FDA EU representative : Emergo Europe B.V. (Netherlands) Japan B IVDR Website EUDAMED record Report an error
PHC FDA EU representative : PHC Europe B.V. (Netherlands) Japan C IVDR EUDAMED record Report an error
Qiagen FDA EU representative : QIAGEN GmbH (Germany) United States – 98/79 Website info@qiagen.com EUDAMED record Report an error
R-Biopharm FDA Germany A IVDR Website EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea C IVDR 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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