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Emdyca

Infectious diseasesBacteriology (infect. immunology/NAT)Other bacteriology immunoassays

Bordetella pertussis / parapertussis

EMDN code W0105011707

13 manufacturers, 56 models including 56 on the market, 7 countries

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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.
ManufacturerCountryRegistered modelsClassContact
TestLine Clinical Diagnostics s.r.o Czechia
15 others
 – 98/79 Website info@testlinecd.com EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany
5 others
 – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Euroimmun FDA Germany
2 others
 – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia – 98/79 Website EUDAMED record Report an error
Viramed FDA Germany B IVDR Website EUDAMED record Report an error
DiaSorin FDA Italy B IVDR Website EUDAMED record Report an error
Mikrogen Germany – 98/79 EUDAMED record Report an error
Orgentec Germany – 98/79 Website EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Vircell Spain B IVDR, 98/79 EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@biotests.com.cn EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain) Hong Kong SAR China – 98/79 Website info@phasesci.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) 7

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
MARDX DIAGNOSTICS, INC. United States Trinity Biotech registered
AMERICAN LABORATORY PRODUCTS COMPANY, LTD. United States Bordetella pertussis IgG ELISA registered
Becton, Dickinson & CO Present in Europe in other categories United States BD Difco™ Bordetella Pertussis Antigen registered
DRG Instruments Gesellschaft mit beschränkter Haftung – Bordetella pertussis IgG ELISA registered
DRG International Inc United States Bordetella pertussis IgG ELISA registered
BIOCHECK, INC. United States – registered
Suzhou TianLong Biotechnology Co., Ltd. Present in Europe in other categories China – registered

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