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

Bacteriology controls - inf.imm.

EMDN code W0105080801

29 manufacturers, 174 models including 172 on the market, 10 countries

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Manufacturers registered in Europe (EUDAMED) 29
  • 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
Microbiologics FDA EU representative : MediMark Europe Sarl. (France) United States
29 others
 A, B IVDR Website info@microbiologics.com EUDAMED record Report an error
Euroimmun FDA Germany
20 others
 – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Mikrogen Germany
19 others
 B IVDR, 98/79 EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) Italy, United States
14 others
 B, C IVDR, 98/79 Website ivdr_dsu@diasorin.com EUDAMED record Report an error
LGC Clinical Diagnostics FDA EU representative : MediMark Europe Sarl. (France) United States
4 others
 B IVDR, 98/79 EUDAMED record Report an error
Biologicals Quality Control Netherlands
2 others
 B IVDR Website info@bioqcontrol.com EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
1 other
 C IVDR, 98/79 Website info@szyhlo.com EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China B, C IVDR Website EUDAMED record Report an error
Dialab Austria – 98/79 Website office@dialab.at EUDAMED record Report an error
Operon FDA Spain B IVDR, 98/79 Website infoeudamed@operon.es EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China – 98/79 info@alltests.com.cn EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland) C IVDR Website EUDAMED record Report an error
Quimica Clinica Aplicada Spain – 98/79 Website EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea B, C IVDR Website EUDAMED record Report an error
Abbott FDA EU representative : Emergo Europe B.V. (Netherlands) United States – 98/79 Website EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium) South Korea C IVDR, 98/79 Website marketing@boditech.co.kr EUDAMED record Report an error
Diagnostics Belgium – 98/79 Website EUDAMED record Report an error
Meridian Bioscience FDA EU representative : Meridian Bioscience Europe S.r.l. (Italy) United States C IVDR Website EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 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
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United Kingdom (ex Northern Ireland) B, C IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Spinreact Spain – 98/79 Website EUDAMED record Report an error
Technogenetics FDA Italy B, C IVDR Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) United States – 98/79 info@acrobiotech.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States – 98/79 quality@healgen.com EUDAMED record Report an error
Human Germany – 98/79 Website EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Microprofit EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 EUDAMED record Report an error
Chemelex No model still on the market Spain – 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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