Infectious diseasesMultiple parameters - (infect. immunology/NAT)Multiple bacteria / fungi panels

Gram+ - gram- - fungi - multiplex assays

EMDN code W0105070203

11 manufacturers, 31 models including 31 on the market, 7 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 11

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
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
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	Enteric Bacterial Detection and Monitoring Kit (24)3 refs98/79 Enteric Bacterial Detection and Monitoring Kit (48)3 refs98/79	– 98/79	Website 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
Poly Diagnostics	Luxembourg	Poly Diagnostics C. parapsilosis, C. tropicalis, C. krusei, RNase P Real-Time PCR kit3 refs	B IVDR	Website info@polydiagnostics.com EUDAMED record Report an error
Vitrosens	Türkiye	LyoSens Gardnerella vaginalis Detection qPCR Kit LYO5798/79	– 98/79	Website info@vitrosens.com EUDAMED record Report an error

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