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

All infectious diseases controls - NAT

EMDN code W0105080808

25 manufacturers, 209 models including 207 on the market, 13 countries

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Manufacturers registered in Europe (EUDAMED) 25
  • 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
Vircell Spain
23 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Qnostics EU representative : WMDE B.V. (Netherlands) United Kingdom (ex Northern Ireland)
21 others
 – 98/79 quality@qnostics.com EUDAMED record Report an error
Microgenics FDA EU representative : B·R·A·H·M·S GmbH (Germany) United States
20 others
 – 98/79 Website EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
16 others
 – 98/79 EUDAMED record Report an error
LGC Clinical Diagnostics FDA EU representative : MediMark Europe Sarl. (France) United States
11 others
 B IVDR EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States
10 others
 – 98/79 quality@healgen.com EUDAMED record Report an error
Biologicals Quality Control Netherlands
7 others
 B IVDR Website info@bioqcontrol.com EUDAMED record Report an error
DiaMex Germany
5 others
 B IVDR Website EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States
2 others
 B IVDR, 98/79 Website ivdr_dsm@diasorin.com EUDAMED record Report an error
ElitechGroup FDA Italy
1 other
 – 98/79 Website EUDAMED record Report an error
Maine Molecular Quality Controls FDA EU representative : QbD RepS BV (Belgium) United States
1 other
 B IVDR, 98/79 Website info@mmqci.com EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany) Taiwan – 98/79 service@credodxbiomed.com EUDAMED record Report an error
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH Germany – 98/79 Website info@gfeblut.de EUDAMED record Report an error
Microbix FDA EU representative : Obelis s.a. (Belgium) Canada B IVDR Website customer.service@microbix.com EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 ra.danwei@danwei-bio.com EUDAMED record Report an error
Etablissement Francais Du Sang France B IVDR, 98/79 EUDAMED record Report an error
Vazyme EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China B IVDR, 98/79 EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States B, C IVDR EUDAMED record Report an error
SpeeDx FDA EU representative : MedEnvoy Global BV (Netherlands) Australia B IVDR Website regulatory@speedx.com.au EUDAMED record Report an error
Genetic Signatures FDA EU representative : mdi Europa GmbH (Germany) Australia – 98/79 Website RAQA@geneticsignatures.com EUDAMED record Report an error
Abacus Diagnostica Finland – 98/79 info@abacusdiagnostica.com EUDAMED record Report an error
bioMérieux FDA France – 98/79 EUDAMED record Report an error
Biosynex France – 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
Cube Dx Austria – 98/79 Website info@cubedx.com 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

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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