Manufacturer

Ecolidx

CzechiaLegal entities : Ecoli Dx, s.r.o.

First countries of placing on the market declared in EUDAMED : Czechia

44 categories, 79 models including 79 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	ePure Bacterial DNA Extraction Kit ePure Blood DNA Extraction Kit 200 ePure CFC DNA Extraction Kit ePure FFPE DNA Extraction Kit ePure Forensic DNA Extraction Kit 4 others ePure STD DNA Extraction Kit ePure TB DNA Extraction Kit ePure Tissue DNA Extraction Kit ePure Viral Nucleic Acid Extraction Kit	A IVDR	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	eSens Florocenosis/Aerobes QT PCR kit98/79 eSens Florocenosis/Bacterial Vaginosis QT PCR kit98/79 eSens Florocenosis/Candida QT PCR kit98/79 eSens Florocenosis/Mycoplasmas QT PCR kit98/79 eSens Gardnerella vaginalis/Lactobacillus sp. QT PCR kit98/79 4 others eSens M.genitalium ML/FQ resistance QT PCR kit98/79 eSens N.gonorrhoeae/M.genitalium/T.vaginalis QL PCR kit98/79 eSens Ureaplasma parvum/urealyticum QL PCR kit98/79 eSens Ureaplasma/M.genitalium/M.hominis QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	eSens Gardnerella vaginalis QL PCR kit98/79 eSens MDR KPC/OXA QL PCR kit98/79 eSens MDR MBL QL PCR kit98/79 eSens MDR MCR-1 QL PCR kit98/79 eSens MDR MTC QL PCR kit98/79 2 others eSens MDR VRE QL PCR kit98/79 eSens Trichomonas vaginalis QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex NA reagents	W0105070201	eSens Acute intestinal infections QL PCR kit98/79 eSens Escherichioses QL PCR kit98/79 eSens MTC QL PCR kit98/79 eSens N.meningitidis/H.influenzae/S.pneumoniae QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Other virus combinations - multiplex NA reagents	W0105070302	eSens ARVI screen QL PCR kit98/79 eSens EBV/HHV6 QT PCR kit98/79 eSens Influenza virus A H5/H7/H9 QL PCR kit98/79 eSens Rotavirus/Norovirus/Astrovirus QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Hhv-6,7,8 - NA reagents	W0105040524	eSens HHV6 QT PCR kit98/79 eSens HHV7 QT PCR kit98/79 eSens HHV8 QT PCR kit98/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	eSens HPV HR 14 genotype QT PCR kit98/79 eSens HPV HR 14 screen/16,18,45 genotype QT PCR kit98/79 eSens HPV HR 16/18 genotype QT PCR kit98/79	– 98/79	EUDAMED record Report an error
Candida albicans - NA reagents	W0105060402	eSens Candida albicans QL PCR kit98/79 eSens Candida albicans/glabrata/krusei QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Streptococcal detection by NA reagents	W0105011102	eSens Streptococcus agalactiae QT PCR kit98/79 eSens Streptococcus pyogenes QT PCR kit98/79	– 98/79	EUDAMED record Report an error
Urogenital mycoplasma detection by NA reagents	W010501080302	eSens Mycoplasma genitalium QL PCR kit98/79 eSens Mycoplasma hominis QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	eSens Bordetella pertussis/bronchiseptica/parapertussis QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Brucella - NA reagents	W0105011601	eSens Brucella sp. QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Cryptococcus	W0105060303	eSens Cryptococcus neoformans QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	eSens Dengue virus type QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Diphtheria (corynebacterium d.) - NA reagents	W0105011608	eSens Corynebacterium diphtheriae/tox genes QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	eSens EBV QT PCR kit98/79	– 98/79	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	eSens Enterovirus QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	eSens Neisseria gonorrhoeae QL PCR kit98/79	– 98/79	EUDAMED record Report an error
H. pylori detection by NA reagents	W0105010403	eSens Helicobacter pylori QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Hepatitis a virus - NA reagents	W0105020105	eSens HAV QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Hepatitis b virus - genotyping - NA reagents	W0105020218	eSens HBV genotype QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Hepatitis c virus (HCV) genotyping - NA reagents	W0105020309	eSens HCV genotype QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Hepatitis g virus - NA reagents	W0105020606	eSens HGV QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	eSens HSV 1/2 genotype QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Legionella detection by NA reagents	W0105010503	eSens Legionella pneumophila QT PCR kit98/79	– 98/79	EUDAMED record Report an error
Leptospira - NA reagents	W0105011604	eSens Leptospira QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Listeria detection by NA reagents	W0105011305	eSens Listeria monocytogenes QT PCR kit98/79	– 98/79	EUDAMED record Report an error
Lyme detection by NA reagents	W0105010605	eSens Borrelia miyamotoi QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	eSens TBEV QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	eSens JCV/BKV QT PCR kit98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	eSens Mycobacterium tuberculosis/bovis/BCG QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Mycology NA reagents - other	W0105060499	eSens NA Mycosis Multiplex98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	ePure	A IVDR	EUDAMED record Report an error
Other HPV - NA reagents	W0105041005	eSens HPV LR 6/11 genotype QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Parvovirus b 19 - NA reagents	W0105040509	eSens Parvovirus B19 QT PCR kit98/79	– 98/79	EUDAMED record Report an error
Pneumocystis - NA reagents	W0105060405	eSens Pneumocystis jirovecii QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Syphilis detection by NA reagents	W0105010305	eSens Treponema pallidum QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Tick borne diseases - multiplex NA reagents	W0105070507	eSens TBEV/Borrelia/Anaplasma/Ehrlichia QL PCR Kit98/79	– 98/79	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	eSens Yellow fever virus QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Ureaplasma detection by NA reagents	W010501080303	eSens Ureaplasma sp. QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Varicella zoster - NA reagents	W0105040904	eSens VZV QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	eSens Poliovirus QL PCR kit98/79	– 98/79	EUDAMED record Report an error
West nile virus - NA reagent	W0105040526	eSens WNV QL PCR kit98/79	– 98/79	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	eSens Zika virus QL PCR kit98/79	– 98/79	EUDAMED record Report an error

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