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70 device results listed.

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PATHFAST TB LAM Ag

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301162
Basic UDI-DI: 4987595PF1231KXJ
Reference: 30116
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

04562185395280

TRCR MB-Lysis Reagent

IVD Class AIVDR 2017/746No longer on the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185395280
Basic UDI-DI: 456018921000200273
Reference: 0056202
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® QuantiFERON®-TB Gold Plus II

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104388
Basic UDI-DI: 80567713110903Y
Reference: 311090
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

LIAISON® QuantiFERON®-TB Gold Plus II

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104395
Basic UDI-DI: 80567713110954A
Reference: 311095
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:40

Manufacturer products View details

LIAISON® QuantiFERON®-TB Gold Plus

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104180
Basic UDI-DI: 80567713110503L
Reference: 311050
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

LIAISON® QuantiFERON®-TB Gold Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103282
Basic UDI-DI: B-08056771103282
Reference: 311010
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

D-697994388Nc046228Y

Non-tuberculous Mycobacterium Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Nc046228Y
Basic UDI-DI: B-697994388Nc046228Y
Reference: Nc046
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Fa046WR98

Non-tuberculous Mycobacterium Nucleic Acid Detection Kit (Fluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Fa046WR98
Basic UDI-DI: B-697994388Fa046WR98
Reference: Fa046
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS IGRA-TB

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133045336
Basic UDI-DI: 880613300610C4
Reference: SMFP-99
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

MYCOPROSAFE

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: SALUBRIS, Inc.
Manufacturer SRN: US-MF-000038921
UDI-DI: 00860011123408
Basic UDI-DI: 08600111234TM240B2
Reference: TM240
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: France
Authorised representative: DIAGNOTIS SAS
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

MycoDDR™ Trident™ Mycobacterium Digestion and Decontamination Reagent Sets

Mycobacterium Digestion and Decontamination Reagent Sets

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IMMY, Inc.
Manufacturer SRN: US-MF-000025165
UDI-DI: 00816387021039
Basic UDI-DI: 081638702MycoNF
Reference: TBNN1010-2.5
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:21

Manufacturer products Authorised representative products Authorised representative actors View details

MAX

BD MAX™ STR

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904438068
Basic UDI-DI: 038290CDZXTPZWHH
Reference: 443806
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710780

300194

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710780
Basic UDI-DI: B-08885019710780
Reference: 300194
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710728

300193

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710728
Basic UDI-DI: B-08885019710728
Reference: 300193
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ MTB/XDRe Detection