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

Bacteriology immunoassay - other

EMDN code W0105011799

41 manufacturers, 97 models including 91 on the market, 12 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 41

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
VMRD FDA EU representative : MediMark Europe Sarl. (France)	United States	Fuller Laboratories by VMRD Anaplasma phagocytophilum and Ehrlichia chaffeensis MIF IgG Antibody Kit E21X-12098/79 Fuller Laboratories by VMRD Anaplasma phagocytophilum and Ehrlichia chaffeensis MIF IgM Antibody Kit E21M-12098/79 Fuller Laboratories by VMRD Anaplasma phagocytophilum IFA IgG Antibody Kit EEG-12098/79 Fuller Laboratories by VMRD Anaplasma phagocytophilum IFA IgM Antibody Kit EEM-12098/79 Fuller Laboratories by VMRD Bartonella henselae IFA Human IgG Antibody Kit BHG-12098/79 5 others Fuller Laboratories by VMRD Bartonella henselae IFA Human IgM Antibody Kit BHM-12098/79 Fuller Laboratories by VMRD Francisella tularensis and Brucella abortus MIF IgG Antibody Kit FTG-12098/79 Fuller Laboratories by VMRD Francisella tularensis and Brucella abortus MIF IgM Antibody Kit FTM-12098/79 Fuller Laboratories by VMRD Orientia tsutsugamushi MIF IgG Antibody Kit OTG-10098/79 Fuller Laboratories by VMRD Orientia tsutsugamushi MIF IgM Antibody Kit OTM-10098/79	– 98/79	Website EUDAMED record Report an error
Euroimmun FDA	Germany	Anti-Bartonella henselae IIFT (IgG) FI 219b G2 refs98/79 Anti-Bartonella henselae IIFT (IgM) FI 219b M2 refs98/79 IIFT Mosaic: Bartonella henselae / Bartonella quintana EUROPattern (IgG) FR 219b-1 G2 refs98/79 IIFT: Bartonella henselae / Bartonella quintana (IgG) FI 219b-1 G2 refs98/79 IIFT: Bartonella henselae / Bartonella quintana (IgM) FI 219b-1 M3 refs98/79 1 other IIFT: Bartonella henselae / Bartonella quintana EUROPattern (IgM) FR 219b-1 M2 refs98/79	– 98/79	Website info@euroimmun.de EUDAMED record Report an error
Vircell	Spain	BARTONELLA HENSELAE & QUINTANA IFA IgG PBAHQG98/79 BARTONELLA HENSELAE & QUINTANA IFA IgM PBAHQM98/79 BARTONELLA HENSELAE IFA IgG PBAHEG98/79 BARTONELLA HENSELAE IFA IgM PBAHEM98/79 BARTONELLA HENSELAE VIRCLIA® IgG MONOTEST VCM04698/79 1 other BARTONELLA HENSELAE VIRCLIA® IgM MONOTEST VCM04398/79	– 98/79	EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain)	China	100T/kit98/79 15T/kit98/79 1T/kit98/79 40 T/kit98/79 5T/kit98/79	– 98/79	EUDAMED record Report an error
Nanjing Synthgene Medical Technology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Bacterial vaginosis Rapid Test Kit (Colloidal gold method) CR02898/79 Typhoid Antigen Rapid Test Kit (Colloidal gold method) CR02198/79 Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method) CR02098/79 Vibrio Cholerae O1 Rapid Test Kit (Colloidal gold method) CR03798/79 Vibrio Cholerae O1/O139 Rapid Test Kit (Colloidal gold method) CR03698/79	– 98/79	Website sales@syngenebio.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	CARBA 5 In 1 Rapid Test Cassette GCCRE-T1402a98/79 Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma) GCTB-302a98/79 Tuberculosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCTB-402a98/79 V. cholerae O1 Ag Rapid Test Cassette (Feces) GCVCH(O1)-602a98/79 V. cholerae O1/O139 Ag Combo Rapid Test Cassette (Feces) GCVCH(O1/O9)-602a98/79	– 98/79	EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy)	United States	Anaplasma phagocytophilum IFA IgM98/79 Anaplasma phagocytophilum IFA IgG98/79 Bartonella IFA IgG98/79 Bartonella IFA IgM98/79	– 98/79	Website ivdr_dsm@diasorin.com EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	100 Tests/Kit98/79 200 Tests/Kit98/79 30 Tests/Kit98/79 50 Tests/Kit98/79	– 98/79	Website support@rayto.com EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o	Czechia	BLOT-LINE Anaplasma IgG98/79 BLOT-LINE Anaplasma IgM98/79 EIA PCP IgG98/79 SmartEIA PCP IgG98/79	– 98/79	Website info@testlinecd.com EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Bioline™ Cholera Ag O1/O13998/79 Bioline™ Cholera Ag O1/O139 44FK3098/79 SD BIOLINE Cholera Ag O1/O139 44FK3098/79	– 98/79	Website EUDAMED record Report an error
Beijing Gold Mountainriver Tech Development EU representative : Caretechion GmbH (Germany) and 1 other	China	Bacterial Endotoxin Test (Chromogenic Method)4 refs98/79 Carbapenem-resistant K.N.I.V.O. Detection K-Set (Lateral Flow Assay)98/79 Carbapenem-resistant OXA-23 Detection K-Set (Lateral Flow Assay)98/79	– 98/79	Website marketing@era-bio.com EUDAMED record Report an error
Genobio Pharmaceutical FDA EU representative : Caretechion GmbH (Germany)	China	Bacterial Endotoxin Detection Kit (CLIA)98/79 Carbapenem-resistant K.N.I.V.O. Detection K-Set (Lateral Flow Assay)98/79 MCR Enzyme Detection K-Set (Colloidal Gold Immunochromatography)98/79	– 98/79	Website marketing@era-bio.com EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) and 1 other	China	Typhoid IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Vibrio cholerae O1 and O139 Antigen Rapid Test Kit98/79	– 98/79	office@guoke-medical.com EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	Diphtheria Toxid IgG ELISA98/79 NovaLisa® Bartonella98/79	– 98/79	Website info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	V. cholerae O1 Ag Rapid Test Cassette (Feces) GCVCH(O1)-602a98/79 V. cholerae O1/O139 Ag Rapid Test Cassette (Feces) GCVCH(O1/O9)-602a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Inbios FDA EU representative : AR Experts B.V. (Netherlands)	United States	Scrub Typhus Detect™ IgG ELISA98/79 Scrub Typhus Detect™ IgM ELISA98/79	– 98/79	Website EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/Kit4 refs98/79 QINGLI Strip: 25Tests/Kit4 refs98/79	– 98/79	EUDAMED record Report an error
ARJ Medical FDA EU representative : Obelis s.a. (Belgium)	United States	PYLO-5098/79	– 98/79	EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	Cholera O1 Antigen Fecal Test Kit VCO1-F2398/79	– 98/79	Website contact@diareagent.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	Vibrio Cholerae O1/O139 Antigens Rapid Test Cassette(Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Vibrio cholerae Antigen Test Kit98/79	– 98/79	EUDAMED record Report an error
Chronolab	Spain	Agglutination slide and tube tests with positive and negative controls, 8 x 5 mL, 2 x 1 mL98/79	– 98/79	Website info@chronolab.com EUDAMED record Report an error
Core Technology FDA EU representative : Medunion S.L. (Spain)	China	Leptospira IgG/IgM Test Cassette B270-2098/79	– 98/79	EUDAMED record Report an error
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Typhoid IgG/IgM Rapid Test Strip(whole blood/serum/plasma) A100501S98/79	– 98/79	info@cybereagen.com EUDAMED record Report an error
DiagCor Life Science EU representative : SUNGO Europe B.V. (Netherlands)	Hong Kong SAR China	9202698/79	– 98/79	QARA@diagcorlifescience.com EUDAMED record Report an error
Diagreat EU representative : Medunion S.L. (Spain)	China	Carbapenem Resistant Enterobacteriaceae Rapid Test Kit 25 tests/box	B IVDR	Website info@diagreat.com EUDAMED record Report an error
Diesse FDA	Italy	WW-DAT ADVANCED WWD	C IVDR	Website EUDAMED record Report an error
Dynamiker EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	40 tests/kit98/79	– 98/79	Website marketing@dynamiker.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Cholera O1 Antigen Rapid Test 20Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Rightsign ITYP-C4298/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Candida albicans Antigen Rapid Test HCAL056G98/79	– 98/79	info@jgbiotech.com EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland)	China	StrongStep® Vibrio Cholerae O1/O139 Antigen Combo Rapid Test 20 Tests/box98/79	– 98/79	Website sales@limingbio.com EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland)	Serbia	Verotoxin 1+298/79	– 98/79	Website EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDASCREEN® Clostridium perfringens Enterotoxin3 refs	B IVDR	Website EUDAMED record Report an error
Remel Europe FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	Wellcogen Bacterial Antigen Kit98/79	– 98/79	Website EUDAMED record Report an error
Seramun	Germany	Serazym® Anti-Francisella tularensis98/79	– 98/79	info@seramun.com EUDAMED record Report an error
Spectral Medical FDA EU representative : CEpartner4U (Netherlands)	Canada	ENDOTOXIN ACTIVITY ASSAY (EAATM) KIT EAAST-2098/79	– 98/79	EUDAMED record Report an error
Spinreact	Spain	BACTERIAL ANTIGENS No25 refs98/79	– 98/79	Website EUDAMED record Report an error
Techlab FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Clostridium Perfringens Enterotoxin Test98/79	– 98/79	Website EUDAMED record Report an error
Vitrosens	Türkiye	RapidFor™ Cholera O1 + O139 Test Kit2 refs	B IVDR	Website info@vitrosens.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	Cholera O139 Antigen Rapid Test 20 tests/kit98/79 (no longer marketed) Cholera O139 Antigen Rapid Test 40 tests/kit98/79 (no longer marketed) Mycobacterium Tuberculosis Rapid Test 20 tests/kit98/79 (no longer marketed) Mycobacterium Tuberculosis Rapid Test 40 tests/kit98/79 (no longer marketed) Typhoid Rapid Test 20 tests/kit98/79 (no longer marketed) 1 other Typhoid Rapid Test 40 tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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