ReagentsInfectious diseasesMultiple parameters - (infect. immunology/NAT)

Multiple bacteria / fungi panels

EMDN code W01050702

33 manufacturers, 141 models including 141 on the market, 13 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 33

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
Vitrosens	Türkiye	ChainFor UTI ID-27 Genotyping qPCR Kit CFP1698/79 ChainFor Wound ID-30 Genotyping qPCR Kit CFP1798/79 ChainFor™5 refs ChainFor™ CFP120P2598/79 ChainFor™ CFP157P2598/79 20 others ChainFor™ CFP157P5098/79 ChainFor™ CFP158P10098/79 ChainFor™ CFP158P5098/79 ChainFor™ CFP196P10098/79 ChainFor™ CFP196P2598/79 ChainFor™ CFP197P5098/79 ChainFor™ Sepsis v1.0 Genotyping qPCR Kit3 refs ChainFor™ Sepsis v2.0 Genotyping qPCR Kit3 refs ChainFor™ UTI v1.0 Genotyping qPCR Kit3 refs ChainFor™ UTI ID-27 Genotyping qPCR Kit3 refs LyoSens Gardnerella vaginalis Detection qPCR Kit LYO5798/79 LyoSens™ LYO120WS2498/79 LyoSens™ LYO120WS4898/79 LyoSens™ LYO157WS9698/79 LyoSens™ LYO166WS2498/79 LyoSens™ LYO166WS9698/79 LyoSens™ LYO196WS4898/79 LyoSens™ LYO196WS9698/79 LyoSens™ LYO197WS2498/79 LyoSens™ LYO197WS9698/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Acinetobacter baumannii qPCR Kit2 refs98/79 RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit3 refs98/79 RevoDx Colistin (mcr) resistance qPCR Kit2 refs98/79 RevoDx Enterobacter cloacae qPCR Kit2 refs98/79 RevoDx Enterococcus faecalis qPCR Kit2 refs98/79 8 others RevoDx Enterococcus faecium qPCR Kit2 refs98/79 RevoDx Extended Spectrum Beta-Lactamases (ESBL) Genes (CTX-M, TEM, SHV) qPCR Kit2 refs98/79 RevoDx Klebsiella pneumonia qPCR Kit3 refs98/79 RevoDx Methicillin resistance (mecA/mecC) qPCR Kit2 refs98/79 RevoDx Pseudomonas aeruginosa qPCR Kit2 refs98/79 RevoDx Sepsis Pathogen Detection Kit9 refs98/79 RevoDx Sepsis Pathogen PLUS Detection Kit3 refs98/79 RevoDx Vancomycin resistance (vanA/vanB) qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Microbio EU representative : Qualrep Services B.V. (Netherlands)	Australia	InfectID-BSI B1 Bacterial Detection Kit MRB50098/79 InfectID-BSI B2 Bacterial Detection Kit MRB60098/79 InfectID-BSI B3 Bacterial Detection Kit MRB70098/79 InfectID-BSI B4 Bacterial Detection Kit MRB80098/79 InfectID-BSI B5 Bacterial Detection Kit MRB90098/79 7 others InfectID-BSI B6 Bacterial Detection Kit MRB100098/79 InfectID-BSI Bacterial and Yeast Assay Kit MRB130098/79 InfectID-BSI Bacterial and Yeast Assay Kit MRB1300.598/79 InfectID-BSI Bacterial and Yeast Combined Detection Kit MRB40098/79 InfectID-BSI Y1 Yeast Detection Kit MRB140098/79 InfectID-BSI Y2 Yeast Detection Kit MRB120098/79 InfectID-BSI Y3 Yeast Detection Kit MRB150098/79	– 98/79	Website info@microbio.com.au EUDAMED record Report an error
Cube Dx	Austria	hybcell Bacteria DNA xB98/79 hybcell Fungi DNA xB98/79 hybcell Pathogens DNA xB98/79 PCR-Box Bacteria98/79 PCR-Box Bacteria 48rx-s98/79 4 others PCR-Box Fungi98/79 PCR-Box Fungi 48rx-s98/79 PCR-Box IPC98/79 PCR-Box Resistance2 refs98/79	– 98/79	Website info@cubedx.com EUDAMED record Report an error
AusDiagnostics EU representative : Advena Limited (Malta) and 1 other	Australia	RIDA®Plex Vaginitis and Vaginosis 12 well Step 198/79 RIDA®Plex Vaginitis and Vaginosis 12 well Step 298/79 RIDA®Plex Vaginitis and Vaginosis 8 well Step 198/79 RIDA®Plex Vaginitis and Vaginosis 8 well Step 298/79 Step 1 tubes for Vaginitis and vaginosis 12-well98/79 3 others Step 1 tubes for Vaginitis and vaginosis 8-well98/79 Step 2 Plates for Vaginitis and vaginosis 12-well98/79 Step 2 Plates for Vaginitis and vaginosis 8-well98/79	– 98/79	Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Ingenetix	Austria	BactoReal® Kit Bordetella Multiplex98/79 BactoReal® Kit E. coli & Klebsiella98/79 BactoReal® Kit P. aeruginosa & Enterobacter spp.98/79 BactoReal® Kit S. pneumoniae & Streptococcus spp.98/79 BactoReal® Kit Staphylococcus spp. & S. aureus98/79 2 others BactoReal® Kit vanA & Enterococcus spp.98/79 MycoReal® Kit Candida & A. fumigatus98/79	– 98/79	Website office@ingenetix.com EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks2 refs98/79 Anatolia Geneworks Bosphore Joint Infection Panel Kit v13 refs98/79 Anatolia Geneworks Bosphore Sepsis Screening Kit v33 refs98/79 Anatolia Geneworks Bosphore UTI Panel Kit v42 refs98/79 Anatolia Geneworks Bosphore Wound Panel Kit v13 refs98/79	– 98/79	Website info@anatoliagenetik.com EUDAMED record Report an error
Bioeksen	Türkiye	Bio-Speedy® Bacteria/Fungi qPCR Kit98/79 Bio-Speedy® Sepsis qPCR MX-30L Panel2 refs98/79 Bio-Speedy® Sepsis qPCR MX-30S Panel98/79 Bio-Speedy® Sepsis qPCR MX-30T Panel2 refs98/79 Bio-Speedy® Urinary Tract Infections qPCR Panel5 refs98/79	– 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
Poly Diagnostics	Luxembourg	Poly Diagnostics C. glabrata, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. krusei, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. parapsilosis, C. tropicalis, C. krusei, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. parapsilosis, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. tropicalis, RNase P Real-Time PCR kit3 refs	B IVDR	Website info@polydiagnostics.com EUDAMED record Report an error
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany)	China	Bacterial vaginosis Rapid Test Kit (Colloidal gold method)98/79 Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)98/79 Neisseria Gonorrhoeae Antigen Rapid Test Kit(Colloidal gold method)98/79 Trichomonas Vaginalis Antigen Rapid Test Kit (Colloidal gold method)98/79 Trichomonas/Candida Antigen Combo Rapid Test Kit (Colloidal gold method)98/79	– 98/79	sales@syngenebio.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	Bacterial Sepsis Detection and Monitoring Kit (24)3 refs98/79 Enteric Bacterial Detection and Monitoring Kit (24)3 refs98/79 Enteric Bacterial Detection and Monitoring Kit (48)3 refs98/79 Sepsis Detection and Monitoring Kit (24)3 refs98/79	– 98/79	Website EUDAMED record Report an error
Ecolidx	Czechia	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	Website EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit Plus98/79 Drug Resistance Genes Digital PCR Detection Kit98/79 Fungal Digital PCR Detection Kit98/79 Multiplex Infection Pathogens & Resistance Genes Detection Kit DMIR0198/79	– 98/79	EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Acinetobacter baumannii and Canidia albican Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Candida Albicans, Acinetobacter Baumannii and Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Candida Albicans, Cryptococcus Neoformans and Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)2 refs	C IVDR, 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	Sepsi-AMR Real Time PCR kit G61002798/79 Sepsis-Q Real Time PCR Kit G2M804026,G2M804026R98/79 Sepsis-Q Real Time PCR Kit G61002798/79	– 98/79	Website EUDAMED record Report an error
Pilotgene EU representative : Medunion S.L. (Spain)	China	FS98/79 P1198/79 SC98/79	– 98/79	EUDAMED record Report an error
Targetingone EU representative : Medunion S.L. (Spain)	China	Blood pathogens and drug resistance genes digital PCR detection kit BP01-Y2498/79 Blood pathogens and drug resistance genes real-time PCR detection kit BP03-Y2498/79 Pathogens nucleic acid digital PCR detection kit BP02-Y2498/79	– 98/79	EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain)	China	Bacterial Vaginosis Test Kit (Sialidase) Cassette98/79 Candida albicans/Trichomonas vaginalis/Gardnerella Antigen Combo Test Kit (ColloidalGold) Cassette98/79	– 98/79	sales@dbluemedical.com EUDAMED record Report an error
Id Solutions	France	iSolutions™ Enteric Bacteria & C. difficile Fullplex qPCR IS-ENTBAC-CD-100 (FR) - Boîtes98/79 iSolutions™ Essential Enteric Bacteria Fullplex qPCR IS-ENTBAC-100 (FR) - Boîtes98/79	– 98/79	Website info@id-solutions.fr EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Shigella/Entamoeba histolytica Nucleic Acid Detection Kit (Fluorescence)98/79 Shigella/Entamoeba histolytica Nucleic Acid Detection Kit Nc01098/79	– 98/79	EUDAMED record Report an error
Qiagen FDA	Germany	QIAstat-Dx BCID GN Plus AMR Panel QIAstat-Dx BCID GPF Plus AMR Panel	C IVDR	Website info@qiagen.com EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain)	China	10 tests/kit7 refs98/79 50 tests/kit7 refs98/79	– 98/79	sale@rocgene.com EUDAMED record Report an error
Shenzhen Chenghui Medical Technology EU representative : HUMISS TRADING S. L. (Spain)	China	Blood Culture Pathogen and Antimicrobial Resistance Gene (G+&Fungi&AMR) Nucleic Acid Detection Kit 1.198/79 Blood Culture Pathogen and Antimicrobial Resistance Gene (G-&AMR) Nucleic Acid Detection Kit 1.198/79	– 98/79	EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	Triplex Real-Time PCR Kit for Detection of Aspergillus, Cryptococcus neoformans and Pneumocystis98/79	– 98/79	EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Candida albicans，Trichomonas vaginalis，Gardnerella Antigen combined Test Kit98/79	– 98/79	EUDAMED record Report an error
BioFire Diagnostics FDA EU representative : bioMérieux SA (France)	United States	BioFire® Blood Culture Identification 2 (BCID2) Panel2 refs	C IVDR	EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruVue98/79	– 98/79	EUDAMED record Report an error
Dynamiker EU representative : JOYSUN GROUP S.L.U (Spain)	China	20 tests98/79	– 98/79	Website marketing@dynamiker.com EUDAMED record Report an error
Euroimmun FDA	Germany	EUROArray Dermatomycosis MN 28504 refs98/79	– 98/79	Website info@euroimmun.de EUDAMED record Report an error
Operon FDA	Spain	Respiratory Bacterial Panel Strip 3.095.XXX.YY.ZZZ98/79	– 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Ureaplasma urealyticum (UU) and Neisseria Gonorrhoeae (NG) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	MultNAT Blood Culture Identification Panel2 refs98/79	– 98/79	Website service@bioustar.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	YARA/SEPSİS PANELİ MAKSİ KİTİ	C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error

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