GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS

EMDN W0105070201

Parent W01050702 MULTIPLE BACTERIA / FUNGI PANELS

Registry term list. Not a clinical opinion. 70 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
LyoSens™	08685214525574	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685214529671	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685214529725	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685214529756	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685214529879	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685214529909	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685214529954	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550542	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550559	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MycoReal® Kit Candida & A. fumigatus	09120110506184	Ingenetix GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Pathogens nucleic acid digital PCR detection kit	06974689626643	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
QIAstat-Dx BCID GN Plus AMR Panel	04053228049371	QIAGEN GmbH	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
QIAstat-Dx BCID GPF Plus AMR Panel	04053228049395	QIAGEN GmbH	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Six Candida Species Nucleic Acid Detection Kit (Digital PCR Method)	06975578360167	Pilot Gene Technology (Hangzhou) Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Six Carbapenem-resistant Gene Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)	06974795550344	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Six Carbapenem-resistant Gene Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)	06974795550351	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)	06955792701069	Sansure Biotech Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)	06955792714656	Sansure Biotech Inc.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)	06955792731264	Sansure Biotech Inc.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Ureaplasma urealyticum (UU) and Neisseria Gonorrhoeae (NG) Diagnostic Kit (PCR-Fluorescence Probing)	06974674892473	Shenzhen Zijian Biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED