MYCOBACTERIAL DETECTION BY NA REAGENTS

EMDN W0105010703

Parent W01050107 MYCOBACTERIA GENUS + SPECIES

Registry term list. Not a clinical opinion. 219 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
Allplex™ NTM Typing	08809240102404	Seegene, Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Allplex™ NTM Typing	08809240102411	Seegene, Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
alphaCube MTB	04262381760249	gerbion GmbH & Co. KG	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ANDiS MTB Detection Kit	06973685471097	3D Biomedicine Science & Technology Co., Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ANDiS MTB RIF/INH Resistance Detection Kit	06973685471103	3D Biomedicine Science & Technology Co., Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Anyplex™ MTB/NTMe Real-time Detection	08809240100509	Seegene, Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Anyplex™ MTB/NTMe Real-time Detection	08809240100516	Seegene, Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Anyplex™ MTB/NTMe Real-time Detection	08809240103838	Seegene, Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® MTB/NTM qPCR Kit	08681877455425	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® MTB/NTM qPCR Kit	08681877455432	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® MTB/NTM qPCR Kit	08681877455449	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® MTB/NTM qPCR Kit	08681877455456	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® MTB qPCR Kit	08681877455463	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® MTB qPCR Kit	08681877455470	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® MTB qPCR Kit	08681877455487	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Bio-Speedy® MTB qPCR Kit	08681877455494	Bioeksen AR GE Teknolojileri Anonim Şirketi	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08683548257246	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08684595031308	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08684595032954	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526137	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526144	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526151	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526236	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526243	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526267	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526427	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526434	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ChainFor™	08685214526441	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Detection Kit for Mycobacterium Tuberculosis Complex Nucleic Acid (PCR-Fluorescence Probing)	06928103012406	Daan Gene Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Detection Kit for Mycobacterium Tuberculosis Complex Nucleic Acid (PCR-Fluorescence Probing)	06928103012413	Daan Gene Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Detection Kit for Mycobacterium Tuberculosis Complex Nucleic Acid (PCR-Fluorescence Probing)	06928103012420	Daan Gene Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)	06974081870361	SINGUWAY BIOTECH INC.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Diagnostic Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence)	06928103000502	Daan Gene Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Diagnostic Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence)	06928103000519	Daan Gene Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Diagnostic Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence)	06928103000526	Daan Gene Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
diarellaMTB real time PCR Kit	04260199010693	gerbion GmbH & Co. KG	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EasyNAT MTC Assay	06973492240138	Ustar Biotechnologies (Hangzhou) Ltd.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EUYI IP-10 Rapid Test for MTB	06976457970040	Shenzhen YOUYI Bioscience Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EUYI MTB DNA Test	06976457970026	Shenzhen YOUYI Bioscience Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
FlashDetect	06974767393054	Coyote Bioscience Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
FlashDetect	06974767393061	Coyote Bioscience Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
FlashDetect	06977739170035	Coyote Bioscience Co., Ltd.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
(Fluorescence PCR Melting Curve Analysis)	06974566303995	Zhuhai Encode Medical Engineering Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Fluorion	08698898740072	IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
FluoroType® MTBDR VER 2.0	04049055003938	Hain Lifescience GmbH	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
FluoroType® MTB VER 1.0	04049055003754	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
FluoroType® Mycobacteria VER 1.0	04049055003761	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
FR013a-Mycobacterium tuberculosis-Doubel Check (Ready to use Realtime PCR-Kit)	04262420430003	Genekam Biotechnology AG	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Galaxy MTB/RIF Assay	06975447582119	Igenesis(Shanghai)Co.,Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
GeneMind	06974968583537	GeneMind Biosciences Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED