Infectious diseasesBacteriology (infect. immunology/NAT)Escherichia coli

E. coli detection by NA reagents

EMDN code W0105011503

12 manufacturers, 35 models including 35 on the market, 5 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 12

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	RIDA®GENE E. coli Stool Panel I98/79 RIDA®GENE EAEC98/79 RIDA®GENE EHEC/EPEC98/79 RIDA®GENE ETEC/EIEC98/79 RIDA®UNITY E. coli Stool Panel I 2 others 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
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
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	– 98/79	Website info@vitrosens.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
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
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
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
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

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