Infectious diseasesInfectious immunology - rapid tests & point of careBacteriology - RT & POC

Clost. diff. incl GDH and/or toxin a and b - RT & POC

EMDN code W0105090106

31 manufacturers, 121 models including 119 on the market, 9 countries

On the market in Models on the market only Manufacturer country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Manufacturer	Country	Registered models	Class	Contact
Hangzhou Alltest Biotech EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Clostridium difficile GDH + Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICD-635B98/79 Clostridium difficile GDH + Toxin A + Toxin B Control SCCD-D-L98/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-63598/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-635B98/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette with LF READER PLUS98/79 9 others Clostridium difficile GDH+Toxin A/B Test Cassette FI-CD-60298/79 Clostridium difficile GDH/Toxin A/Toxin B Test Cassette FI-CD-602B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-62598/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-625B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-R625B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette ICDT-R625B98/79 Clostridium difficile Toxin A/ toxin B Combo Test Cassette FI-CDT-62598/79 Clostridium difficileToxin A+Toxin B Combo Rapid Test Cassette2 refs98/79 Combo Prueba Rápida Clostridium difficile GDH+Toxina A+Toxina B en Casete98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 1 test/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 10 tests/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 100 tests/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 25 tests/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 5 tests/kit98/79 9 others C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 50 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Acro Biotech EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	Clostridium difficile GDH Rapid Test Cassette ICDG-R60298/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICD-63598/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test ICD-ACO63798/79 Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test Cassette ICD-R635B98/79 Clostridium difficile GDH+Toxin A/B Test Cassette ACO-CD-60298/79 4 others Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-R625B98/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICDT-62598/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICDT-625B98/79 Clostridium difficile Toxin A/ toxin B Combo Test Cassette (Feces) ACO-CDT-62598/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Acesolab EU representative : VidaQuick Biotech S.L. (Spain)	United States	Clostridium difficile GDH & Toxin A &Toxin B Combo Test F35-CD98/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test F37-CD98/79 Clostridium difficile GDH FIA Test98/79 Clostridium difficile GDH Test F02-CDG98/79 Clostridium difficile GDH+Toxin A/B FIA Test98/79 3 others Clostridium difficile GDH/Toxin A/Toxin B FIA Test98/79 Clostridium difficile Toxin A &Toxin B Combo Test F25-CDT98/79 Clostridium difficile Toxin A/Toxin B Combo FIA Test98/79	– 98/79	info@acesolab.com EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	Clostridium difficile GDH Assay F11-CDG01C698/79 Clostridium difficile GDH Rapid Test L11-CDG01C698/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test L11-CD03C698/79 Clostridium difficile GDH+Toxin A/B Assay F11-CD01C698/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test L11-CDT02C698/79 3 others Clostridium difficile Toxin A/ toxin B Combo Assay F11-CDT01C698/79 Clostridium difficile Toxin A/Toxin B Combo Assay F11-CDT02C698/79 One Step Clostridium difficile GDH+ Toxin A +Toxin B Combo Test98/79	– 98/79	Website info@kylinew.com EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain)	China	Clostridium difficile GDH & Toxin A &Toxin B Combo Test CD-6C398/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test CD-6F398/79 Clostridium difficile GDH Rapid Test Cassette ICDG-60298/79 Clostridium difficile GDH Test CDG-6C198/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-635B98/79 2 others Clostridium difficile Toxin A &Toxin B Combo Test CDT-6C298/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette ICDT-625B98/79	– 98/79	info@bitrumed.com.cn EUDAMED record Report an error
Biotical	Spain	biotical C. difficile GDH Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile GDH +1 C. Negativo universal)98/79 biotical C. difficile GDH Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile GDH)98/79 biotical C. difficile GDH Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical C. difficile Toxins A + B Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile Toxins A + B +1 C. Negativo universal)98/79 biotical C. difficile Toxins A + B Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile Toxins A + B)98/79 1 other biotical C. difficile Toxins A + B Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79	– 98/79	Website EUDAMED record Report an error
Rapid Labs EU representative : VidaQuick Biotech S.L. (Spain)	United Kingdom (ex Northern Ireland)	Clostridium difficile GDH Test Device-Feces D-FICLOSD1098/79 Clostridium difficile GDH Test Device-Feces D-FICLOSD2598/79 Clostridium difficile GDH+Toxin A/B Test Device-Feces D-FICDGTABD1098/79 Clostridium difficile GDH+Toxin A/B Test Device-Feces D-FICDGTABD2598/79 Clostridium difficile Toxin A/Toxin B Combo Test Device-Feces D-FICDTABD1098/79 1 other Clostridium difficile Toxin A/Toxin B Combo Test Device-Feces D-FICDTABD2598/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	C. DIFFICILE TOXIN A/TOXIN B/GDH RAPID TEST KIT VISD075 C. DIFFICILE/ GDH HIZLI TEST KİTİ Clostridium Difficile Toxin A+B Rapid Test VISD125 SOLUNUM YOLU PATOJENLERİ TARAMA 24 PARÇALI KİTİ RESPIRATORY PATHOGENS SCREENING 24P KIT TOXIN A/B RAPID TEST KIT VISD034	B IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain)	China	Clostridium difficile GDH Rapid Test Cassette CLO-2-F98/79 Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test CGAB-7-F98/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette CTAB-5-F98/79 Clostridium diffilcile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette98/79	– 98/79	info@actest.com.cn EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany)	China	Accu-Tell® Clostridium difficile GDH Cassette (Feces)98/79 Accu-Tell® Clostridium difficile GDH +Toxin A+ Toxin B Combo Cassette (Feces)98/79 Accu-Tell® Clostridium difficile Toxin A+ Toxin B Combo Cassette (Feces)98/79	– 98/79	sales@accubiotech.com EUDAMED record Report an error
Certest	Spain	CerTest C. difficile GDH+Toxin A+B3 refs CerTest Clostridium difficile antigen GDH3 refs CerTest Clostridium difficile Toxin A+B3 refs	B IVDR	Website quality@certest.es EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	C.difficile GDH + Toxin A/B Combo Rapid Test P240898/79 C.difficile GDH Rapid Test P240998/79 C.difficile Toxin A/B Rapid Test P241098/79	– 98/79	Website info@gensurebio.com EUDAMED record Report an error
Healgen EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) GCCD(GDH)-602a98/79 Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces) GCCD-602a98/79 Clostridium difficile Toxin A&B Rapid Test Cassette (Feces) GCCD(Toxin A/B)-602a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
nal von minden	Germany	NADAL® C. difficile GDH Ag Test2 refs98/79 NADAL® C. difficile Toxin A/B Test2 refs98/79 NADAL® C. difficile Toxin A/B+GDH Test2 refs98/79	– 98/79	Website info@nal-vonminden.com EUDAMED record Report an error
Operon	Spain	SIMPLE 2A-Bdiff / STICK 2A-Bdiff 9.038.XXX.YY.ZZZ98/79 SIMPLE GDH / STICK GDH 9.045.XXX.YY.ZZZ3 refs Simple GDH-Toxins 9.065.XXX.YY.ZZZ3 refs	B IVDR, 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	Clostridioides difficile Detection and Monitoring Kit (24)3 refs98/79 Clostridioides difficile Detection and Monitoring Kit (48)3 refs98/79	– 98/79	Website EUDAMED record Report an error
Biomaxima	Poland	Clostridium difficile GDH kasetki 20 szt2 refs Clostridium difficile GDH+A+B kas. 20szt	B IVDR	Website info@biomaxima.com EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain)	Canada	Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICD-635B98/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICD-635B(CT)98/79	– 98/79	ra02@citestdiagnostics.com EUDAMED record Report an error
Tongzhoubio EU representative : VidaQuick Biotech S.L. (Spain)	China	Clostridium Difficile GDH Test Kit YI062-600298/79 Clostridium difficile Toxin A/ toxin B Combo Test Kit YI010-602598/79	– 98/79	EUDAMED record Report an error
Vircell	Spain	VIRAPID® CLOSTRIDIUM DIFFICILE (GDH) Ag VRC004 VIRAPID® CLOSTRIDIUM DIFFICILE (GDH/TOX A/TOX B) Ag VRC005	B IVDR	EUDAMED record Report an error
Vivachek EU representative : Lotus NL B.V. (Netherlands)	China	C. difficile Toxin A/B Rapid Test VICT98/79 C. difficile Toxin A/B+GDH Rapid Test VITG98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Aaz Productions Le Materiel Biomedical	France	TetaQuick98/79	– 98/79	EUDAMED record Report an error
Acmexbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Acmex Cassette2 refs98/79	– 98/79	info@acmexbio.com EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : CEpartner4U (Netherlands)	China	R200-11298/79	– 98/79	EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	C. difficile GDH FIA GDH-F23F398/79	– 98/79	Website contact@diareagent.com EUDAMED record Report an error
Biosynex	France	BIOSYNEX C. difficile GDH	B IVDR	Website reglementaire@biosynex.com EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Clostridium Difficile Related Test Kit Ir04298/79	– 98/79	EUDAMED record Report an error
R-Biopharm	Germany	RIDA®Quick C. difficile GDH Toxin A/B Combi2 refs	B IVDR	Website EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands)	China	C. difficile Toxin A/B Rapid Test GICD98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	Clostridium Difficile Toxin A+B Rapid Test98/79 (no longer marketed) Clostridium Difficile Toxin AB+GDH Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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