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169 device results listed.

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Mycobacterium Tuberculosis (TB) Real Time PCR Kit

Mycobacterium Tuberculosis (TB) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229664
Basic UDI-DI: B-06971042229664
Reference: RD-1060-02
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacterium Tuberculosis (TB) real time PCR Kit

Mycobacterium Tuberculosis (TB) real time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227646
Basic UDI-DI: B-06971042227646
Reference: RD-0060-02
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

FluoroType® Mycobacteria VER 1.0

FluoroType® Mycobacteria VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003761
Basic UDI-DI: B-04049055003761
Reference: 1880017
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:06

Manufacturer products View details

FluoroType® MTB VER 1.0

FluoroType® MTB VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003754
Basic UDI-DI: B-04049055003754
Reference: 61196
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:06

Manufacturer products View details

GenoType CMdirect VER 1.0

GenoType CMdirect VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003372
Basic UDI-DI: B-04049055003372
Reference: 295
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

GenoType NTM-DR VER 1.0

GenoType NTM-DR VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003235
Basic UDI-DI: B-04049055003235
Reference: 29712
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

GenoType MTBDRsl VER 2.0

GenoType MTBDRsl VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003181
Basic UDI-DI: B-04049055003181
Reference: 31796A
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

GenoType MTBDRsl VER 2.0

GenoType MTBDRsl VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003174
Basic UDI-DI: B-04049055003174
Reference: 317A
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

GenoType LepraeDR VER 1.0

GenoType LepraeDR VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002597
Basic UDI-DI: B-04049055002597
Reference: 320
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType Mycobacterium CM VER 2.0

GenoType Mycobacterium CM VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000425
Basic UDI-DI: B-04049055000425
Reference: 29996A
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType Mycobacterium CM VER 2.0

GenoType Mycobacterium CM VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000418
Basic UDI-DI: B-04049055000418
Reference: 299A
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType Mycobacterium AS VER 1.0

GenoType Mycobacterium AS VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000395
Basic UDI-DI: B-04049055000395
Reference: 298
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType MTBC VER 1.X

GenoType MTBC VER 1.X

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000319
Basic UDI-DI: B-04049055000319
Reference: 301
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Detection Kit (Melting Curve)

Mycobacterium Tuberculosis Nucleic Acid and Rifampicin 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-0000128072020E2P6
Basic UDI-DI: B-0000128072020E2P6
Reference: HWTS-RT074
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 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

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

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-0000128072000E0NL
Basic UDI-DI: B-0000128072000E0NL
Reference: HWTS-RT147
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 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

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)

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)

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

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

FluoroType® MTBDR VER 2.0

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