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169 device results listed.

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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

MYCOBACTERIUM REALTIME PCR KIT

RTPCR016

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290463
Basic UDI-DI: 843604032RTPCR01601W4
Reference: RTPCR016-LP
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:33

Manufacturer products View details

EasyNAT MTC Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240138
Basic UDI-DI: 697349224U2010032C000DP
Reference: U20103
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731882

Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731882
Basic UDI-DI: B-06955792731882
Reference: S3274E-48
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731875

Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731875
Basic UDI-DI: B-06955792731875
Reference: S3274E-24
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

06955792730984

Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730984
Basic UDI-DI: B-06955792730984
Reference: S3018E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730977
Basic UDI-DI: B-06955792730977
Reference: S3018E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

06950917910586

Mycobacterium Tuberculosis Nucleic Acid Detection Kit (Fluorescent PCR)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Triplex International Biosciences (China) Co., LTD.
Manufacturer SRN: CN-MF-000001097
UDI-DI: 06950917910586
Basic UDI-DI: B-06950917910586
Reference: C011939
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors 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: 04049055002627
Basic UDI-DI: 40490550300001000TP
Reference: 30496A
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 22:41

Manufacturer products View details