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220 device results listed.

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Mycobacterium Tuberculosis Isoniazid Resistance Mutation Detection Kit(Melting Curve)

Mycobacterium Tuberculosis Isoniazid Resistance Mutation Detection Kit (Melting Curve)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807171092PW
Basic UDI-DI: B-000012807171092PW
Reference: HWTS-RT137
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071420A1PP
Basic UDI-DI: B-0000128071420A1PP
Reference: HWTS-RT144
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071390DAS4
Basic UDI-DI: B-0000128071390DAS4
Reference: HWTS-RT105
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)

48 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807042309NR
Basic UDI-DI: B-000012807042309NR
Reference: HWTS-RT105C
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)

50 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807042208NJ
Basic UDI-DI: B-000012807042208NJ
Reference: HWTS-RT105A
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-00001280704210BNX
Basic UDI-DI: B-00001280704210BNX
Reference: HWTS-RT105B
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MTBC OneStep Nested Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930061
Basic UDI-DI: 89080153043B268NV
Reference: 3B269
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ IGRA-TB 25

ichroma™ IGRA-TB

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133045299
Basic UDI-DI: 880613300138BZ
Reference: CFPC-86-1
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 MTB-RIF/INH

M10-MTB-02

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722929
Basic UDI-DI: 88001117IPCA01MA19XT
Reference: M10-MTB-02/11MTB30A
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

TDC

TDC %4

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi
Manufacturer SRN: TR-MF-000021258
UDI-DI: 08698918035546
Basic UDI-DI: 869891803040059A
Reference: 04005020
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:55

Manufacturer products View details

DECOMICS

DECONTAMINATION AND CONCENTRATION KITS

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: Innovative Biotechnology Organization Trade Limited Company
Manufacturer SRN: TR-MF-000037634
UDI-DI: 08681677201437
Basic UDI-DI: 86816772DKHK
Reference: DEC010
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:33

Manufacturer products View details

ichroma™ IGRA-TB for 8

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048986
Basic UDI-DI: 880613300138BZ
Reference: CFPC-86-2
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

QFT-Plus Reference Lab Pack

QuantiFERON-TB Gold Plus (QFT-Plus)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228015963
Basic UDI-DI: 4053228RTBQFT0000000001W8
Reference: 622822
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:22

Manufacturer products View details

04049095200069

RIDA®QUICK TB

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095200069
Basic UDI-DI: 4049095TN88020000UD
Reference: TN8802
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

04049095200052

RIDASCREEN® TB

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095200052
Basic UDI-DI: 4049095TC88060000MU
Reference: TC8806
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

FluoroType® MTBDR VER 2.0

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003938
Basic UDI-DI: 40490550300001005TZ
Reference: 62896
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

GenoType MTBDRplus VER 2.0

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002610
Basic UDI-DI: 40490550300001000TP
Reference: 304A
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

DECOCENT

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: DIAGNOTIS SAS
Manufacturer SRN: FR-MF-000035861
UDI-DI: 03770032939094
Basic UDI-DI: 3770032939DCC050S4
Reference: DCC050
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:14

Manufacturer products View details

DECOMICS

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: DIAGNOTIS SAS
Manufacturer SRN: FR-MF-000035861
UDI-DI: 03770032939087
Basic UDI-DI: 3770032939DEC010SE
Reference: DEC010
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:14

Manufacturer products View details

MYCOPROSAFE

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: DIAGNOTIS SAS
Manufacturer SRN: FR-MF-000035861
UDI-DI: 03770032939070
Basic UDI-DI: 3770032939MPS2305X
Reference: MPS230
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:14

Manufacturer products View details