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14 device results listed.

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Tuberculosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCTB-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCTB-402aHGNZ
Basic UDI-DI: B-GCTB-402aHGNZ
Reference: GCTB-402a
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma)

GCTB-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCTB-302aHGNL
Basic UDI-DI: B-GCTB-302aHGNL
Reference: GCTB-302a
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

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

RapidFor™ Tuberculosis IgG/IgM Rapid Test Kit

VMD37

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941445
Basic UDI-DI: B-08683347941445
Reference: VMD37
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:04

Manufacturer products 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

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

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

Tuberculosis Antibody Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302820
Basic UDI-DI: B-06974566302820
Reference: ITA-812
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

06974323011842

Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011842
Basic UDI-DI: B-06974323011842
Reference: IH021
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

06974323011835

Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011835
Basic UDI-DI: B-06974323011835
Reference: IH021
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

06974323011828

Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011828
Basic UDI-DI: B-06974323011828
Reference: IH021
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis IgG/IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910629
Basic UDI-DI: B-06974238910629
Reference: HTB068T
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

TB IgG/IgM Rapid Test Kit

25 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580842
Basic UDI-DI: 697518250G118333C
Reference: G11833
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details