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Infectious diseasesOther virology tests (infect. immunology/NAT)Coronavirus

Coronavirus - NA reagents

EMDN code W0105041106

61 manufacturers, 143 models including 141 on the market, 14 countries

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Manufacturers registered in Europe (EUDAMED) 61
  • 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
Molbio Diagnostics EU representative : QbD RepS BV (Belgium) India
3 others
 – 98/79 Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Ablsa Luxembourg
2 others
 – 98/79 Website contact@ablsa.com EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) Canada
2 others
 – 98/79 sales@orientgene.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China
1 other
 – 98/79 EUDAMED record Report an error
Immundiagnostik FDA Germany – 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
altona Diagnostics FDA Germany – 98/79 info@altona-diagnostics.com EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 EUDAMED record Report an error
Thermofisher FDA EU representative : Life Technologies Europe B.V. (Netherlands) United States – 98/79 EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye B IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi Türkiye – 98/79 Website EUDAMED record Report an error
Capitalbiotech EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website info@kogene.co.kr 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
Poly Diagnostics Luxembourg B IVDR Website info@polydiagnostics.com EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website info@seegene.com EUDAMED record Report an error
Shanghai BioGerm Medical Technology EU representative : MedNet EC-REP GmbH (Germany) and 1 other China – 98/79 EUDAMED record Report an error
Vircell Spain – 98/79 EUDAMED record Report an error
Vitassay Spain – 98/79 Website info@vitassay.com EUDAMED record Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
AD Nucleis France – 98/79 Website EUDAMED record Report an error
Bioeksen Türkiye – 98/79 Website info@bioeksen.com.tr EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Cepheid FDA EU representative : Cepheid AB (Sweden) United States – 98/79 Website EUDAMED record Report an error
Certest Spain B IVDR Website quality@certest.es 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
Geneproof Czechia – 98/79 Website support@geneproof.com EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany) China – 98/79 EUDAMED record Report an error
Mikrogen Germany – 98/79 EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany) United States – 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Progenie molecular S.L.U Spain – 98/79 EUDAMED record Report an error
R-Biopharm FDA Germany B IVDR, 98/79 Website EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain) China – 98/79 sale@rocgene.com EUDAMED record Report an error
TIB MOLBIOL Syntheselabor Germany – 98/79 Website EUDAMED record Report an error
Vazyme EU representative : Obelis s.a. (Belgium) and 1 other China – 98/79 EUDAMED record Report an error
Vitrosens Türkiye B IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China B IVDR, 98/79 Website info@sansure.com.cn EUDAMED record Report an error
1drop EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website sales@1drop.co.kr EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany) United States B IVDR EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) Singapore – 98/79 Website EUDAMED record Report an error
Anchor Diagnostics Germany – 98/79 info@anchor-diagnostics.com EUDAMED record Report an error
Appolon Bioteck France – 98/79 Website contact@appolonbioteck.com EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States B IVDR Website EUDAMED record Report an error
Beijing Microfuture Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
bioMérieux FDA France B IVDR EUDAMED record Report an error
Biosynex France – 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
Dianabiotech Czechia – 98/79 Website info@dianabiotech.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
FRIZ Biochem Germany B IVDR Website info@frizbiochem.de EUDAMED record Report an error
gerbion Germany – 98/79 info@gerbion.com EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States B IVDR EUDAMED record Report an error
Id Solutions France – 98/79 Website info@id-solutions.fr EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 support@igenesisbio.com EUDAMED record Report an error
PathoFinder Netherlands – 98/79 Website info@pathofinder.com EUDAMED record Report an error
PaxGenBio EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website EUDAMED record Report an error
Pluslife EU representative : Kingsmead Service B.V. (Netherlands) China – 98/79 Website ra@pluslife.com EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 sales@singuway.com 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.

Other manufacturers known in the United States (FDA) 6

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.

ManufacturerCountryBrandsFDA clearance
Life Technologies Corporation United States Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay Kit Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control K233453 (2024)
Roche Molecular Systems, Inc. United States cobas® SARS-CoV-2 Qualitative 192T cobas® SARS-CoV-2 Qualitative Control Kit cobas® SARS-CoV-2 Qualitative 480T K240867 (2025)
Biofire Defense, LLC United States BioFire® COVID-19 Test 2 K221460 (2022)
Jiangsu Bioperfectus Technologies Co., Ltd. Present in Europe in other categories – COVID-19 Coronavirus Real Time PCR Kit registered
823404997 United States – registered
Roche Diagnostics Operations Inc. United States – registered

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