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
BactoReal® Kit Bordetella Multiplex	09120110509512	Ingenetix GmbH	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
BactoReal® Kit E. coli & Klebsiella	09120110506122	Ingenetix GmbH	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
BactoReal® Kit P. aeruginosa & Enterobacter spp.	09120110506139	Ingenetix GmbH	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
BactoReal® Kit S. pneumoniae & Streptococcus spp.	09120110506146	Ingenetix GmbH	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
BactoReal® Kit Staphylococcus spp. & S. aureus	09120110506153	Ingenetix GmbH	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
BactoReal® Kit vanA & Enterococcus spp.	09120110506160	Ingenetix GmbH	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® Bacteria/Fungi qPCR Kit	08681877454480	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® Urinary Tract Infections qPCR Panel	08681877455692	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® Urinary Tract Infections qPCR Panel	08681877455715	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® Urinary Tract Infections qPCR Panel	08681877455722	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® Urinary Tract Infections qPCR Panel	08681877455739	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® Urinary Tract Infections qPCR Panel	08681877455746	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Blood pathogens and drug resistance genes digital PCR detection kit	06974689626636	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Blood pathogens and drug resistance genes real-time PCR detection kit	06974689626650	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Carbapenem-resistant Gene Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550566	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Carbapenem-resistant Gene Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550573	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08684595036297	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08684595036303	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08684595036310	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526335	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526342	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526359	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214529596	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214529626	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214529640	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214529794	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214529817	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214529831	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor UTI ID-27 Genotyping qPCR Kit	08683548256911	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor Vaginosis ID-30 Genotyping qPCR Kit	08683548257215	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor Wound ID-30 Genotyping qPCR Kit	08683548257222	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Dermatophyte Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550580	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Dermatophyte Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550597	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ESKAPE Multipathogenic Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550320	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ESKAPE Multipathogenic Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550337	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EUROArray Dermatomycosis	04049016135401	EUROIMMUN Medizinische Labordiagnostika AG	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EUROArray Dermatomycosis	04049016135418	EUROIMMUN Medizinische Labordiagnostika AG	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EUROArray Dermatomycosis	04049016135425	EUROIMMUN Medizinische Labordiagnostika AG	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EUROArray Dermatomycosis	04049016135432	EUROIMMUN Medizinische Labordiagnostika AG	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Five Candida Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550283	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Five Candida Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550290	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Five Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550306	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Five Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)	06974795550313	RocGene (Xuzhou) Technology Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
iSolutions™ Enteric Bacteria & C. difficile Fullplex qPCR	03760367181251	ID SOLUTIONS	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
iSolutions™ Essential Enteric Bacteria Fullplex qPCR	03760367181671	ID SOLUTIONS	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
LyoSens™	08684998279086	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
LyoSens™	08684998279116	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
LyoSens™	08684998279161	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
LyoSens™	08685214525499	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
LyoSens™	08685214525536	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED