Infectious diseasesBacteriology (infect. immunology/NAT)Mycobacteria genus + species

Mycobacterial detection by NA reagents

EMDN code W0105010703

67 manufacturers, 186 models including 186 on the market, 13 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 67

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Vitrosens	Türkiye	ChainFor™9 refs ChainFor™ CFP164P2598/79 ChainFor™ CFP82P10098/79 ChainFor™ CFP82P2598/79 ChainFor™ CFP82P5098/79 10 others ChainFor™ CFP94P5098/79 ChainFor™ CFP95P10098/79 LyoSens™ LyoSens™ LYO164WS2498/79 LyoSens™ LYO164WS4898/79 LyoSens™ LYO82WS4898/79 LyoSens™ LYO82WS9698/79 LyoSens™ LYO94WS2498/79 LyoSens™ LYO94WS9698/79 LyoSens™ LYO95WS4898/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Xiamen Zeesan Biotech FDA EU representative : Lotus NL B.V. (Netherlands)	China	MDR-TB Test Kit (MMCA)98/79 MDR-TB Test Kit (Sanity 2.0)98/79 MTB Test Kit98/79 MTB Test Kit (Sanity 2.0)98/79 MTB/EMB Test Kit (MMCA)98/79 7 others MTB/FQ Test Kit (MMCA)98/79 MTB/MDR Test Kit (Sanity 2.0)98/79 MTB/PZA Test Kit98/79 MTB/SL Test Kit (MMCA)98/79 MTB/STR Test Kit (MMCA)98/79 Mycobacteria Identification Kit (MMCA)98/79 Mycobacteria Identification Kit (Sanity 2.0)98/79	– 98/79	info@zsandx.com EUDAMED record Report an error
Hain Lifescience	Germany	FluoroType® MTB VER 1.098/79 FluoroType® MTBDR VER 2.0 FluoroType® Mycobacteria VER 1.098/79 GenoType CMdirect VER 1.098/79 GenoType LepraeDR VER 1.098/79 6 others GenoType MTBC VER 1.X98/79 GenoType MTBDRplus VER 2.02 refs GenoType MTBDRsl VER 2.02 refs98/79 GenoType Mycobacterium AS VER 1.098/79 GenoType Mycobacterium CM VER 2.02 refs98/79 GenoType NTM-DR VER 1.098/79	C IVDR, 98/79	EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	MTB Detection and Monitoring Kit (24)3 refs98/79 MTB Detection and Monitoring Kit (48)3 refs98/79 MTB Detection and Monitoring Kit (96)3 refs98/79 MTB/MDR Detection and Monitoring Kit (24)3 refs98/79 MTB/MDR Detection and Monitoring Kit (48)3 refs98/79 5 others MTB/MDR Detection and Monitoring Kit (96)3 refs98/79 MTB/NTM Detection and Monitoring Kit (24)3 refs98/79 MTB/NTM Detection and Monitoring Kit (48)3 refs98/79 MTB/NTM Detection and Monitoring Kit (96)3 refs98/79 TB-XDR Detection and Monitoring Kit (24)3 refs98/79	– 98/79	Website EUDAMED record Report an error
Encode EU representative : Medunion S.L. (Spain)	China	(Fluorescence PCR Melting Curve Analysis) MTB and RFP Drug Resistance Gene Mutation Detection Kit 24 tests/kit98/79 MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis) MTB and Drug Resistance Gene Mutation Detection Kit 48tests/kit98/79 MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis) MTB and RFP Drug Resistance Gene Mutation Detection Kit 48tests/kit98/79 MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis) MTB and RFP/INH Drug Resistance Gene Mutation Detection Kit 48tests/kit98/79 MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis) MTB and RFP/INH Drug Resistance Gene Mutation Detection Kit 24tests/kit98/79 5 others NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis) 24Tests/Kit98/79 NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis) 48Tests/Kit98/79 NTM Drugs Susceptibility Test Kit 10Tests/Kit98/79 NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis) 24Tests/Kit98/79 NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis) 48Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	Med4Me Tuberculosis Panel G2MMAP1000198/79 MTB-NTM Multiplex Real-Time PCR Kit G2M70742198/79 MTB-NTM Multiplex Real-Time PCR Kit G6100153 refs98/79 MTC-Q Real-Time PCR Kit G2M70732198/79 MTC-Q Real-Time PCR Kit G6100143 refs98/79 4 others TB NGS Test Kit G71001011 refs98/79 TB-Q Comprehensive Real Time PCR Kit for Tuberculosis G2M80312198/79 TB-Q Comprehensive Real Time PCR Kit for Tuberculosis G6100343 refs98/79 W0105010703 G71001098/79	– 98/79	Website EUDAMED record Report an error
Molbio Diagnostics EU representative : QbD RepS BV (Belgium)	India	Truenat MTB Plus 60113000598/79 Truenat MTB Plus 60113002098/79 Truenat MTB Plus 60113002598/79 Truenat MTB Plus 60113005098/79 Truenat MTB-RIF Dx 60121000598/79 3 others Truenat MTB-RIF Dx 60121002098/79 Truenat MTB-RIF Dx 60121002598/79 Truenat MTB-RIF Dx 60121005098/79	– 98/79	Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	EasyNAT MTC Assay EasyNAT MTC/NTM Assay98/79 MultNAT MTC Assay MultNAT MTC/MDR Assay98/79 MultNAT MTC/RIF Assay 3 others MultNAT MTC/XDR Assay98/79 MultNAT NTM Panel98/79 PortNAT TB Assay	C IVDR, 98/79	Website service@bioustar.com EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Freeze-dried Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)98/79 Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)98/79 Mycobacterium Tuberculosis Isoniazid Resistance Mutation Detection Kit(Melting Curve)98/79 Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Detection Kit (Melting Curve)98/79 Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)98/79	– 98/79	marketing@hongweitest.com EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	MTB/RIF Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 MTB/XDR Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Mycobacterium tuberculosis Complex Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Mycobacterium tuberculosis Complex, Mycobacterium avium Complex and Mycobacterium abscessus Complex Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Mycobacterium tuberculosis, Haemophilus influenzae and Streptococcus pneumoniae Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	Website sales@tellgen.com EUDAMED record Report an error
Capitalbiotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	12 tests/kit98/79 20 tests /kit98/79 24 tests/kit98/79 32 tests/kit98/79	– 98/79	EUDAMED record Report an error
Daan Gene EU representative : MDSS GmbH (Germany)	China	20 tests/kit3 refs98/79 Large package, 20 tests/kit98/79 Large package, 48 tests/kit98/79 Single tube, 20 tests/kit98/79	– 98/79	EUDAMED record Report an error
Genmark	Türkiye	geneMAP MTB Detection Kit, 100T98/79 geneMAP MTB/MDR Detection Kit, 50T98/79 geneMAP MTB/NTM Detection Kit, 100T98/79 geneMAP MTB/XDR Detection Kit, 25T98/79	– 98/79	Website info@genmark.com.tr EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E98/79 AMTBC01D-AHG48E, AMTBC01D-AHG96E98/79 CMTBNTM01A-AHG4E98/79 RMTB01-AHG5E, RMTB01-AHG25E98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	AMTBC01-AOG48E； AMTBC01-AOG96E；AMTBC01D-AOG48E； AMTBC01D-AOG96E；98/79 CMTB01A-AOG4E98/79 CMTBNTM01A-AOG4E98/79 RMTB01-AHG5E, RMTB01-AHG25E98/79	– 98/79	EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	101A0205EY，101A0205ED98/79 CMTB01A-AHG4E98/79 CMTBRIF01A-AHG4E98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Mycobacterium Multiplex Nucleic Acid Diagnostic Kit(Multiplex PCR-Fluorescence Probing)98/79 Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)2 refs	C IVDR, 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	MTBC Detection Kit MTBC/NTM TESPİT KİTİ TÜBERKÜLOZ (TB) PCR KİTİ	C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	ANDiS MTB Detection Kit 32tests/kit98/79 ANDiS MTB RIF/INH Resistance Detection Kit 300000000030698/79	– 98/79	EUDAMED record Report an error
Bioeksen	Türkiye	Bio-Speedy® MTB qPCR Kit4 refs98/79 Bio-Speedy® MTB/NTM qPCR Kit4 refs98/79	– 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Mycobacterium Tuberculosis Real Time PCR Kit JB20123NW-25T98/79 Mycobacterium Tuberculosis Real Time PCR Kit JB20123NW-50T98/79	– 98/79	EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	Cowingene MTB and NTM Detection Kit98/79 Cowingene Mycobacterium Tuberculosis Detection Kit98/79	– 98/79	Website EUDAMED record Report an error
Dynamiker EU representative : Lotus NL B.V. (Netherlands)	China	20 tests98/79 50 tests98/79	– 98/79	Website marketing@dynamiker.com EUDAMED record Report an error
Geneproof	Czechia	GeneProof Mycobacterium tuberculosis PCR Kit2 refs98/79 TaqPath™ Menu98/79	– 98/79	Website support@geneproof.com EUDAMED record Report an error
gerbion	Germany	alphaCube MTB98/79 diarellaMTB real time PCR Kit98/79	– 98/79	info@gerbion.com EUDAMED record Report an error
Guangzhou Deaou Gene Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	4 tests/kit98/79 8 tests/kit98/79	– 98/79	EUDAMED record Report an error
PaxGenBio EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	PaxView TB MPCR-ULFA Kit V043198/79 PaxView TB/NTM MPCR-ULFA Kit V040198/79	– 98/79	Website EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain)	China	10 tests/kit2 refs98/79 50 tests/kit2 refs98/79	– 98/79	sale@rocgene.com EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Allplex™ NTM Typing2 refs Anyplex™ MTB/NTMe Real-time Detection3 refs98/79	C IVDR, 98/79	Website info@seegene.com EUDAMED record Report an error
Shenzhen YOUYI Bioscience EU representative : Umedwings Netherlands B.V. (Netherlands)	China	EUYI IP-10 Rapid Test for MTB R4898/79 EUYI MTB DNA Test R4898/79	– 98/79	EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing) TB001-4898/79 Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR Fluorescent Probe Method) TB002-4898/79	– 98/79	sales@singuway.com EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR MTB complex98/79 Vitassay qPCR MTBC/NTM98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	U-CardDxTM 2003 refs98/79 U-Card™ 2006 refs98/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
-Diagnostics EU representative : mdi Europa GmbH (Germany)	United States	Logix Smart MTB Test Kit MTB-K-00798/79	– 98/79	Website EUDAMED record Report an error
3Bblackbio EU representative : Wellkang Ltd (Northern Ireland)	India	TRUPCR® MTBC OneStep Nested Kit3 refs	C IVDR	Website info@3bblackbio.com EUDAMED record Report an error
Ab Analitica	Italy	REALQUALITY RQ-MBT COMPLEX4 refs98/79	– 98/79	customersupport@abanalitica.it EUDAMED record Report an error
Abbott FDA	Germany	RealTime3 refs	C IVDR	Website EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	ZENA MAX Mycobacterium Tuberculosis Real Time PCR Detection Kit98/79	– 98/79	Website info@am-diagnostics.co.uk EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks Bosphore MTBC Detection Kit v23 refs98/79	– 98/79	Website info@anatoliagenetik.com EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland)	United States	MAX	C IVDR	Website EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	PCR-based Mycobacterium Tuberculosis Complex Test Kit (Fluorometric PCR)98/79	– 98/79	EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium)	South Korea	ExAmplex MTB/NTM kit98/79	– 98/79	Website marketing@boditech.co.kr EUDAMED record Report an error
Cepheid FDA	Sweden	Xpert®3 refs98/79	– 98/79	Website EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	FlashDetect3 refs98/79	– 98/79	sales@coyotebio.com EUDAMED record Report an error
Ecolidx	Czechia	eSens Mycobacterium tuberculosis/bovis/BCG QL PCR kit98/79	– 98/79	Website EUDAMED record Report an error
Eiken FDA EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany)	Japan	Loopamp™ MTBC Detection Kit	C IVDR	regulatoryaffairs@eiken.co.jp EUDAMED record Report an error
ElitechGroup FDA	Italy	MTB EXTRA ELITe MGB® Kit98/79	– 98/79	Website EUDAMED record Report an error
Genekam	Germany	FR013a-Mycobacterium tuberculosis-Doubel Check (Ready to use Realtime PCR-Kit)98/79	– 98/79	Website office@genekam.de EUDAMED record Report an error
GeneMatrix EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	NeoPlex™ TBNTM-5 Detection Kit NR1598/79	– 98/79	Website support@genematrix.net EUDAMED record Report an error
Genemind EU representative : Medunion S.L. (Spain)	China	GeneMind 96 tests/kit98/79	– 98/79	regulatoryaffairs@genemind.com EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HA-02398/79	– 98/79	EUDAMED record Report an error
Igenesis Shanghai EU representative : Lotus NL B.V. (Netherlands)	China	12 reactions/kit	C IVDR	support@igenesisbio.com EUDAMED record Report an error
Iontek	Türkiye	Fluorion MTBC QLP 2.1 Real-Time PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium)	South Korea	PowerChek™ MTB/NTM Real-time PCR Kit98/79	– 98/79	Website info@kogene.co.kr EUDAMED record Report an error
PathoFinder	Netherlands	RealAccurate® Quadruplex Mycobacteria PCR kit PF0920-R98/79	– 98/79	Website info@pathofinder.com EUDAMED record Report an error
Pluslife EU representative : Medunion S.L. (Spain)	China	MiniDock MTB Test	C IVDR, 98/79	Website ra@pluslife.com EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	STANDARD™ M10 MTB-RIF/INH M10-MTB-02	C IVDR	Website EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Mycobacterium Tuberculosis (TB) Real Time PCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium)	Japan	TRCReady MTB98/79	– 98/79	csc@tosoh.co.jp EUDAMED record Report an error
Triplex International Biosciences (China) EU representative : Lotus NL B.V. (Netherlands)	China	Mycobacterium Tuberculosis Nucleic Acid Detection Kit (Fluorescent PCR)98/79	– 98/79	Website info@tibchina.com EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit (PCR- Fluorescence Probing ) TB001FD98/79	– 98/79	sales@ukinbio.com EUDAMED record Report an error
Vacure EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Rifampicin-resistant Mycobacterium Tuberculosis Kit (Fluorescent PCR)98/79	– 98/79	EUDAMED record Report an error
Vazyme EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Logilet MTB/RIF Panel DTB01M98/79	– 98/79	EUDAMED record Report an error
Vircell	Spain	MYCOBACTERIUM REALTIME PCR KIT RTPCR0162 refs	C IVDR	EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands)	China	VIUICK98/79	– 98/79	EUDAMED record Report an error

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