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81 device results listed.

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Boditech IGRA-TB Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133049013
Basic UDI-DI: 880613306089DP
Reference: CFPO-294
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 21.09.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-SCSYP-D-LWR
Basic UDI-DI: B-SCSYP-D-LWR
Reference: Syphilis Control
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

ANTIGENOS FEBRILES: CONTROL POSITIVO PROTEUS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155003776
Basic UDI-DI: B-18430155003776
Reference: 999131
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:47

Manufacturer products View details

AGS. FEB. SALMONELLA, CTRL+

ANTIGENOS FEBRILES: CONTROL POSITIVO SALMONELLA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155003769
Basic UDI-DI: B-18430155003769
Reference: 999129
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:47

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Antígenos Febriles: Control Positivo Brucella

ANTIGENOS FEBRILES: CONTROL POSITIVO BRUCELLA

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155003431
Basic UDI-DI: B-18430155003431
Reference: 994611
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:46

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Bacterial Antigen polyvalent control -

5902

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035102114
Basic UDI-DI: B-05404035102114
Reference: 5902
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:37

Manufacturer products View details

Bacterial Antigen polyvalent control +

5901

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035102107
Basic UDI-DI: B-05404035102107
Reference: 5901
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:37

Manufacturer products View details

Chlamydia pn. IgM Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738152
Basic UDI-DI: 692591270317HH
Reference: CC1022
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia pn. IgG Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesInstrumentKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738145
Basic UDI-DI: 692591270316HF
Reference: CC1021
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

POLYVALENT POSITIVE CONTROL

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013104
Basic UDI-DI: 5032384StrepGroupPC2K
Reference: DR0592G
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384503032
Basic UDI-DI: 5032384ImagenSlideChlamB5
Reference: S610930-2
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODXTRA POSITIVE CONTROL

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384519897
Basic UDI-DI: 5032384PathoDxtraPCFJ
Reference: DR0707G
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

KWIK-STIK™ and LYFO DISK™

0262

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357004717
Basic UDI-DI: 0845357002629L
Reference: [0262U] KWIK-STIK™ S. marcescens ATCC 43862™
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

KWIK-STIK™ and LYFO DISK™

0156

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357001600
Basic UDI-DI: 0845357001569L
Reference: [0156L] LYFO DISK™ M. hominis ATCC 15488™
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

KWIK-STIK™ and LYFO DISK™

0151

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357001457
Basic UDI-DI: 0845357001519A
Reference: [0151L] LYFO DISK™ U. parvum ATCC 27813™
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673252113
Basic UDI-DI: B-08431673252113
Reference: 1205211
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:07

Manufacturer products View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673252014
Basic UDI-DI: B-08431673252014
Reference: 1205201
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:07

Manufacturer products View details

LIAISON® Control 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: 08056771104463
Basic UDI-DI: 805677131109142
Reference: 311091
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

LIAISON® Control LymeDetect®

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

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103749
Basic UDI-DI: 80567713110313G
Reference: 311031
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

LIAISON® Control Mycoplasma pneumoniae IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771101219
Basic UDI-DI: 80567713170314S
Reference: 317031
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:39

Manufacturer products View details