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277 device results listed.

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SOFTEC Tuberculosis Rapid Test Kit

SFTB40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616305
Basic UDI-DI: B-08697962616305
Reference: SFTB
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

TaqPath™ Menu | GeneProof™ Mycobacterium tuberculosis PCR Kit

GeneProof Mycobacterium tuberculosis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304072
Basic UDI-DI: B-08595696304072
Reference: A58212
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof Mycobacterium tuberculosis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161950097
Basic UDI-DI: B-08594161950097
Reference: MT/ISEX/025
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

GeneProof Mycobacterium tuberculosis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161950110
Basic UDI-DI: B-08594161950110
Reference: MT/ISEX/100
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

06979502240006

"Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Test Cassette (Rare earth nanorare earth nano fluorescence immunochromatography)"

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06979502240006
Basic UDI-DI: B-06979502240006
Reference: IF031
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)

A480501T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753475843
Basic UDI-DI: B-06976753475843
Reference: A480501T
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

EUYI IP-10 Rapid Test for MTB

R48

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen YOUYI Bioscience Ltd.
Manufacturer SRN: CN-MF-000034584
UDI-DI: 06976457970040
Basic UDI-DI: B-06976457970040
Reference: 100MTI-48
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

EUYI MTB DNA Test

R48

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen YOUYI Bioscience Ltd.
Manufacturer SRN: CN-MF-000034584
UDI-DI: 06976457970026
Basic UDI-DI: B-06976457970026
Reference: 100MTB-48
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis IgG/IgM Test

GITBb

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762494
Basic UDI-DI: B-06976202762494
Reference: GITBb-402
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis IgG/IgM Rapid Test

GITBb

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762296
Basic UDI-DI: B-06976202762296
Reference: GITBb-402
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

06976055490155

4 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000033028
UDI-DI: 06976055490155
Basic UDI-DI: B-06976055490155
Reference: NA
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

06976055490148

8 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000033028
UDI-DI: 06976055490148
Basic UDI-DI: B-06976055490148
Reference: NA
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Qpathnano Mycobacterium Typing and Drug Resistance Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Qitan Taike Biotechnology Ltd., Chengdu
Manufacturer SRN: CN-MF-000040515
UDI-DI: 06976019890137
Basic UDI-DI: B-06976019890137
Reference: OS005011
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Greece
Authorised representative: MedPath GmbH
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

VIUICK

Diagnostic Kit for Mycobacterium Tuberculosis DNA (Real-Time PCR Method)

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Guangzhou Viuick Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000017369
UDI-DI: 06975400320086
Basic UDI-DI: B-06975400320086
Reference: 48 Tests/Kit
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hugomanu Beijing Co.,Ltd.
Manufacturer SRN: CN-MF-000023285
UDI-DI: 06975384800055
Basic UDI-DI: B-06975384800055
Reference: YGZZ022-OS-D-000
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: Abmed Medical Technology Limited
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

MiniDock MTB Test

MTB Nucleic Acid Test Card

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120653
Basic UDI-DI: B-06975327120653
Reference: RM1012202-10
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

GeneMind

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583537
Basic UDI-DI: B-06974968583537
Reference: L000104
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

POCBio Mycobacterium Tuberculosis (TB) Antibody Rapid Test

LATR02-C50

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912094348
Basic UDI-DI: B-06974912094348
Reference: LATR02-C50
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

06974858560228

Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560228
Basic UDI-DI: B-06974858560228
Reference: P121H
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis Antibody Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620650
Basic UDI-DI: B-06974854620650
Reference: P2201525
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details