GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS

EMDN W0105070203

Parent W01050702 MULTIPLE BACTERIA / FUNGI PANELS

Registry term list. Not a clinical opinion. 32 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
BioFire® Blood Culture Identification 2 (BCID2) Panel	00815381020338	BioFire Diagnostics, LLC	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
BioFire® Blood Culture Identification 2 (BCID2) Panel	00815381020345	BioFire Diagnostics, LLC	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Candida albicans，Trichomonas vaginalis，Gardnerella Antigen combined Test Kit	06974854620438	Beijing Jinwofu Bioengineering Technology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Candida/Trichomonas vaginalis/Gardnerella vaginalis Antigen Combo Test Kit (Latex Chromatography Method)	06930317891258	Dynamiker Biotechnology (Tianjin) Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Enteric Bacterial Detection and Monitoring Kit (24)	08684190150541	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Enteric Bacterial Detection and Monitoring Kit (24)	08684190151869	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Enteric Bacterial Detection and Monitoring Kit (24)	08684190153122	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Enteric Bacterial Detection and Monitoring Kit (48)	08684190150558	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Enteric Bacterial Detection and Monitoring Kit (48)	08684190151876	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Enteric Bacterial Detection and Monitoring Kit (48)	08684190153139	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
hybcell Bacteria DNA xB	09120127730053	Cube Dx GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
hybcell Fungi DNA xB	09120127730060	Cube Dx GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
hybcell Pathogens DNA xB	09120127730077	Cube Dx GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
LyoSens Gardnerella vaginalis Detection qPCR Kit	08683548259783	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
PCR-Box Bacteria	09120127730084	Cube Dx GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
PCR-Box Bacteria 48rx-s	09120127730725	Cube Dx GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
PCR-Box Fungi	09120127730091	Cube Dx GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
PCR-Box Fungi 48rx-s	09120127730732	Cube Dx GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
PCR-Box IPC	09120127730114	Cube Dx GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
PCR-Box Resistance	09120127730107	Cube Dx GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
PCR-Box Resistance	09120127730763	Cube Dx GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
RIDA®Plex Vaginitis and Vaginosis 12 well Step 1	09343044006975	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
RIDA®Plex Vaginitis and Vaginosis 12 well Step 2	09343044006968	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
RIDA®Plex Vaginitis and Vaginosis 8 well Step 1	09343044006913	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
RIDA®Plex Vaginitis and Vaginosis 8 well Step 2	09343044006906	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Triplex Real-Time PCR Kit for Detection of Aspergillus, Cryptococcus neoformans and Pneumocystis	06974323010111	Beijing Applied Biological Technologies Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Triplex Real-Time PCR Kit for Detection of Aspergillus, Cryptococcus neoformans and Pneumocystis	06974323011576	Beijing Applied Biological Technologies Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
TruVue	15065023763372	BioFynder Limited	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Vaginitis and vaginosis 12-well	09343044003899	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Vaginitis and vaginosis 12-well	09343044003905	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Vaginitis and vaginosis 8-well	09343044001987	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Vaginitis and vaginosis 8-well	09343044001994	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED