Infectious diseasesParasitology (infect. immunology/NAT)Miscellaneous parasitology immunoassay

Chagas

EMDN code W0105050202

21 manufacturers, 45 models including 45 on the market, 10 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 21

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.

Manufacturer	Country	Registered models	Class	Contact
Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Chagas (eCLIA) 100T98/79 Chagas (eCLIA) 200T98/79 Chagas (eCLIA) 2×50T98/79 Chagas (eCLIA) 50T98/79 Chagas Controls Level 1: 3×1.0 mL, Level 2: 3×1.0 mL98/79	– 98/79	Website EUDAMED record Report an error
Vircell	Spain	CHAGAS ELISA IgG+IgM T102098/79 CHAGAS IFA IgG+IgM PCHAG98/79 CHAGAS TESA ELISA IgG+IgM T102398/79 CHAGAS TESA VIRCLIA® IgG+IgM MONOTEST VCM09998/79 CHAGAS VIRCLIA® IgG+IgM MONOTEST VCM00898/79	– 98/79	EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Chagas Rapid Test Cassette ICHA-30298/79 Chagas Rapid Test Cassette ICHA-40298/79 Chagas Rapid Test Cassette ICHA-R30298/79 Chagas Rapid Test Cassette ICHA-R40298/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	Chagas Rapid Test Cassette (Serum/Plasma) ICHA-30298/79 Chagas Rapid Test Cassette (Whole Blood/Serum/Plasma) ICHA-40298/79 Chagas Rapid Test Cassette CHA2C98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Euroimmun FDA	Germany	Anti-Crimean-Congo fever virus(CCHFV) ELISA (IgG) EI 279a G98/79 Anti-Crimean-Congo fever virus(CCHFV) ELISA (IgM) EI 279a M98/79 Anti-Trypanosoma cruzi ELISA (IgG) EI 2212 G98/79	– 98/79	Website info@euroimmun.de EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	Chagas (Trypanosoma cruzi) IgG98/79 Chagas (Trypanosoma cruzi) IgG ELISA2 refs98/79 NovaLisa® Chagas (Trypanosoma cruzi) IgG2 refs98/79	– 98/79	info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Bioline™ Chagas Ab 49FK102 refs98/79 SD BIOLINE Chagas Ab Rapid 49FK1098/79	– 98/79	Website EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany)	China	Accu-Tell® Chagas Cassette(Whole Blood/Serum/Plasma)98/79 Accu-Tell® Chagas Strip (Whole Blood/Serum/Plasma)98/79	– 98/79	sales@accubiotech.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Chagas Ab Rapid Test Cassette (Serum/Plasma) GCCHA-302a98/79 Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHA-402a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Chagas Ab Rapid Test Cassette (Serum/Plasma) GCCHA-302a98/79 Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHA-402a98/79	– 98/79	EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Chagas Rapid Test Device – S/P D-CHAD4098/79 Chagas Rapid Test Device – WB/S/P98/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain)	China	Chagas Rapid Test (Serum/Plasma) I025-300298/79 Chagas Rapid Test (Whole Blood/Serum/Plasma) I025-400298/79	– 98/79	EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Argentina	Chagatest ELISA lisado2 refs98/79 Chagatest ELISA recombinante v.4.02 refs98/79	– 98/79	Website marketing@wiener-lab.com EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Chagas Ab Rapid Test P2211098/79	– 98/79	EUDAMED record Report an error
Dutch Diagnostics	Netherlands	Chagas Test98/79	– 98/79	Website info@dutch-diagnostics.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Chagas Ab Combo Rapid Test 25Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	RapiT.Cruzi Rapid Antibody Test kit for Trypanosoma cruzi G2MR17255098/79	– 98/79	Website EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Chagas IgG/IgM Rapid Test HCHA011T98/79	– 98/79	info@jgbiotech.com EUDAMED record Report an error
IBL International	Germany	Chagas (Trypanosoma cruzi) IgG ELISA98/79	– 98/79	Website EUDAMED record Report an error
Ldbio Diagnostics	France	CHAGAS WB IgG3 refs98/79	– 98/79	Website EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands)	China	Chagas Ab Rapid Test GICA98/79	– 98/79	info@vivachek.com EUDAMED record Report an error

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