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218 device results listed.

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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

Med4Me Tuberculosis Panel

G2MMAP10001

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2MMAP10001LS
Basic UDI-DI: B-G2MMAP10001LS
Reference: G2MMAP10001-ill; G2MMAP10001-TF; G2MMAP10001-MG
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

TB-Q Comprehensive Real Time PCR Kit for Tuberculosis

G2M803121

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M803121F2
Basic UDI-DI: B-G2M803121F2
Reference: G2M803121,G2M803121R
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

MTC-Q Real-Time PCR Kit

G2M707321

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M707321FT
Basic UDI-DI: B-G2M707321FT
Reference: G2M707321,G2M707321R
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB Plus

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: D-8908007989460CA
Basic UDI-DI: B-8908007989460CA
Reference: 601130005, 601130020, 601130025, 601130050
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 20:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002RMTB01N5WX

RMTB01-AHG5E, RMTB01-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002RMTB01N5WX
Basic UDI-DI: B-81649002RMTB01N5WX
Reference: RMTB01-AHG5E, RMTB01-AHG25E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMTBC01HNZE

AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMTBC01HNZE
Basic UDI-DI: B-81649002AMTBC01HNZE
Reference: AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMTBC01DNVDE

AMTBC01D-AHG48E, AMTBC01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMTBC01DNVDE
Basic UDI-DI: B-81649002AMTBC01DNVDE
Reference: AMTBC01D-AHG48E, AMTBC01D-AHG96E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis Interferon-Gamma Release Assay Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346441
Basic UDI-DI: B-20850076346441
Reference: CCTBIG-401a
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB-RIF Dx

601210025