ReagentsInfectious diseasesBacteriology (infect. immunology/NAT)

Escherichia coli

EMDN code W01050115

20 manufacturers, 51 models including 51 on the market, 9 countries

On the market in Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 20

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
R-Biopharm FDA	Germany	RIDASCREEN® Verotoxin3 refs RIDA®GENE E. coli Stool Panel I98/79 RIDA®GENE EAEC98/79 RIDA®GENE EHEC/EPEC98/79 RIDA®GENE ETEC/EIEC98/79 3 others RIDA®UNITY E. coli Stool Panel I RIDA®UNITY E. coli Stool Panel III RIDA®UNITY EHEC/EPEC	C IVDR, 98/79	Website EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Diarrheagenic E.coli Genotype Real Time PCR Kit98/79 E. Coli O157：H7 Real Time PCR Kit98/79 Enteroadhesive E.Coli (EAEC) Real Time PCR Kit98/79 Enterohemorrhagic E.Coli (EHEC) Real Time PCR Kit98/79 Enteroinvasive E.Coli (EIEC) Real Time PCR Kit98/79 1 other Enteropathogenic E.Coli (EPEC) Real Time PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Diarrheagenic Escherichia coli (DEC) Detection Kit2 refs98/79 RevoDx Diarrheagenic Escherichia coli (DEC) version 2.0 Detection Kit2 refs98/79 RevoDx E. coli O157:H7 qPCR Kit2 refs98/79 RevoDx Escherichia coli K1 qPCR Kit2 refs98/79 RevoDx Escherichia coli qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Pro-Lab Diagnostics EU representative : Advena Limited (Malta)	Canada	Bulk E.coli O157 Latex Reagent98/79 Bulk E.coli O157 Negative Control Latex Reagent98/79 E. coli Non-O157 Identification Kit98/79 E.coli O157 Antiserum98/79 E.coli O157 Latex Test Reagent Kit2 refs98/79	– 98/79	Website support@pro-lab.com EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor EHEC + EPEC + EIEC Detection qPCR Kit CFP5198/79 ChainFor ETEC + EIEC Detection qPCR Kit CFP5298/79 LyoSens E. coli EHEC, EPEC & EIEC Detection qPCR Kit LYO2498/79 LyoSens E. coli ETEC + EIEC Detection qPCR Kit LYO2598/79 RapidFor™ E.coli O157:H7 Test Kit2 refs	B IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Poly Diagnostics	Luxembourg	Poly Diagnostics E. coli Pathotyping Panel I Real-Time PCR kit3 refs Poly Diagnostics E. coli Pathotyping Panel II Real-Time PCR kit3 refs Poly Diagnostics E. coli Pathotyping Panel III Real-Time PCR kit3 refs Poly Diagnostics E.coli, RNase P Real-Time PCR kit3 refs	B IVDR	Website info@polydiagnostics.com EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany)	China	E. coli Pathotyping (5) Real Time PCR Kit YJB11201NW-25T98/79 E. coli Pathotyping (5) Real Time PCR Kit YJB11201NW-50T98/79	– 98/79	EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	DRYSPOT E. COLI O157 E. COLI O157 TEST KIT	B IVDR	Website EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	5 Diarrhea Escherichia coli Nucleic Acid Detection Kit (PCR-Fluorescence Probing)2 refs98/79 Enteropathogenic Escherichia Coli Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Techlab FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	SHIGA TOXIN CHEK98/79 SHIGA TOXIN QUIK CHEK	B IVDR, 98/79	Website EUDAMED record Report an error
altona Diagnostics FDA	Germany	RealStar® EHEC PCR Kit 2.098/79	– 98/79	info@altona-diagnostics.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	Real-time PCR Diagnostic Kit for Rapid Detection of Enterohemorrhagic E. coli (EHEC)98/79	– 98/79	EUDAMED record Report an error
Clonit	Italy	O157 – E. COLI CARD CLZC101098/79	– 98/79	Website info@clonit.it EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : VidaQuick Biotech S.L. (Spain)	China	E.coli O157: H7 Antigen Rapid Test98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Rightsign SEC-C6198/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain)	China	12 reactions/kit98/79	– 98/79	support@igenesisbio.com EUDAMED record Report an error
Remel Europe FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay98/79	– 98/79	Website EUDAMED record Report an error
Seramun	Germany	Serazym® Verotoxin 1+298/79	– 98/79	info@seramun.com EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Escherichia Coli DNA Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR E. coli pathotypes98/79	– 98/79	Website info@vitassay.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) 10

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.

Manufacturer	Country	Brands	FDA clearance
Ssi Diagnostica A/S Present in Europe in other categories	Denmark	E. coli O134 serum high titer, 1 mL E. coli O168 serum, 1 mL E. coli O10 serum, 1 mL E. coli O71 serum high titer, 1 mL E. coli OK O145 serum, 3 mL E. coli H25 serum, 5 mL	registered
PRO-LAB, INCORPORATED Present in Europe in other categories	Canada	Prolex E. coli Non-O157 Identification Kit Prolex E. coli O157 Latex Test Reagent Kit (50 tests) Prolex E. coli O157 Latex Test Reagent Kit (100 tests) Prolex E. coli O26 Latex Reagent Prolex E. coli O111 Latex Reagent Prolex E. coli O91 Latex Reagent	K903714 (1991)
MAST GROUP LIMITED Present in Europe in other categories	United Kingdom	Mast Assure Antisera Mast Assure Escherichia coli O26 antiserum Mast Assure Mast Assure Escherichia coli O111 Antiserum	registered
Becton, Dickinson & CO Present in Europe in other categories	United States	BD Difco™ Escherichia coli O Antiserum O157 BD Difco™ Escherichia coli H Antiserum H7	registered
AGILENT TECHNOLOGIES SINGAPORE PTE LTD Present in Europe in other categories	–	Poly Rb A-Escherichia Coli	registered
Meridian Bioscience, Inc. Present in Europe in other categories	United States	PREMIER EHEC	registered
Remel Co. Present in Europe in other categories	United States	REMEL	K933457 (1994)
Changchun Merydi Bio-Tech Co., Ltd.	China	–	registered
Changchun Wancheng Bio-Electron Co., Ltd.	China	–	registered
Jilin Hongyi Bio-Tech Co., Ltd.	China	–	registered

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