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
GeneProof Mycobacterium tuberculosis PCR Kit	08594161950097	GeneProof a.s.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GeneProof Mycobacterium tuberculosis PCR Kit	08594161950110	GeneProof a.s.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType CMdirect VER 1.0	04049055003372	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType LepraeDR VER 1.0	04049055002597	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType MTBC VER 1.X	04049055000319	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType MTBDRplus VER 2.0	04049055002610	Hain Lifescience GmbH	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType MTBDRplus VER 2.0	04049055002627	Hain Lifescience GmbH	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType MTBDRsl VER 2.0	04049055003174	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType MTBDRsl VER 2.0	04049055003181	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType Mycobacterium AS VER 1.0	04049055000395	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType Mycobacterium CM VER 2.0	04049055000418	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType Mycobacterium CM VER 2.0	04049055000425	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GenoType NTM-DR VER 1.0	04049055003235	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Logilet MTB/RIF Panel	06973315739245	Nanjing Vazyme Medical Technology Co.,Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Loopamp™ MTBC Detection Kit	04033145191377	EIKEN CHEMICAL CO., LTD.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08684595035566	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08684595038987	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08684595038994	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685115803412	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685115803450	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685115809643	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685115809681	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685115809728	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685115809766	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685214525253	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685214525291	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LyoSens™	08685214525338	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MAX	00382904438784	Becton, Dickinson and Company	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MDR-TB Test Kit (MMCA)	06956299702917	Xiamen Zeesan Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MDR-TB Test Kit (Sanity 2.0)	06956299702856	Xiamen Zeesan Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MiniDock MTB Test	06975327120653	Guangzhou Pluslife Biotech Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MiniDock MTB Test	06975327121292	Guangzhou Pluslife Biotech Co., Ltd	Class C	Certificate valid Snapshot 2026-10-13 · Link to EUDAMED
MTB Detection and Monitoring Kit (24)	08684190150619	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Detection and Monitoring Kit (24)	08684190151937	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Detection and Monitoring Kit (24)	08684190153191	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Detection and Monitoring Kit (48)	08684190150626	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Detection and Monitoring Kit (48)	08684190151944	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Detection and Monitoring Kit (48)	08684190153207	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Detection and Monitoring Kit (96)	08684190150633	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Detection and Monitoring Kit (96)	08684190151951	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Detection and Monitoring Kit (96)	08684190153214	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)	06974566304008	Zhuhai Encode Medical Engineering Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)	06974566304015	Zhuhai Encode Medical Engineering Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)	06974566304022	Zhuhai Encode Medical Engineering Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)	06974566304046	Zhuhai Encode Medical Engineering Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB/EMB Test Kit (MMCA)	06956299702948	Xiamen Zeesan Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB/FQ Test Kit (MMCA)	06956299702887	Xiamen Zeesan Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB-MDR	06976037880127	Hangzhou Zhunxin Biotechnology	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB/MDR Detection and Monitoring Kit (24)	08684190150671	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MTB/MDR Detection and Monitoring Kit (24)	08684190151999	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED