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DxFlex Daily QC Fluorospheres

DxFLEX Daily QC Fluorospheres

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590730031
Basic UDI-DI: 150995901C39283S6
Reference: C39283
EMDN: W0103080699
EMDN description: REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

DxFLEX Sheath Fluid

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590670825
Basic UDI-DI: 150995901LS-1-SheathND
Reference: B73613
EMDN: W0103080699
EMDN description: REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Flow-Count Fluorospheres

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590542450
Basic UDI-DI: 150995901FLUROSPHRSRP
Reference: 7547053
EMDN: W0103080499
EMDN description: FLOW CYTOMETRY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOPREP Reagent System

IMMUNOPREP REAGENT SYSTEM

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590542443
Basic UDI-DI: 150995901LSPREPREAGENT35
Reference: 7546999
EMDN: W0103080699
EMDN description: REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent

CYTO-STAT tetraCHROME

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590540272
Basic UDI-DI: 150995901LSMABEA
Reference: 6607073
EMDN: W0103080106
EMDN description: ANTIBODIES FOR LYMPHOCYTE SUBTYPING
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNO-TROL Low Cells

Flow Cytometry Control Cells

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590540210
Basic UDI-DI: 150995901LSIMMUNOTROLXV
Reference: 6607098
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Not Applicable

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382906644534
Basic UDI-DI: 038290YNAJNVPIJQ
Reference: 664453
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: -
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 01.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

Not Applicable

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903411122
Basic UDI-DI: 038290YNAJNVPIJQ
Reference: 341112
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: -
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 30.06.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

08594208060116

DryFlowEx PNH High-Sensitivity Assay Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: EXBIO Praha, a.s.
Manufacturer SRN: CZ-MF-000033468
UDI-DI: 08594208060116
Basic UDI-DI: 859420806ED775074
Reference: ED7750
EMDN: W0103080199
EMDN description: MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

08594208060055

DryFlowEx TBNK 6-color

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagentSingle use

Manufacturer: EXBIO Praha, a.s.
Manufacturer SRN: CZ-MF-000033468
UDI-DI: 08594208060055
Basic UDI-DI: 859420806ED77367A
Reference: ED7736
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

08594208060048

CD34 QuantiFlowEx Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: EXBIO Praha, a.s.
Manufacturer SRN: CZ-MF-000033468
UDI-DI: 08594208060048
Basic UDI-DI: 859420806ED70806A
Reference: ED7080
EMDN: W01030803
EMDN description: STEM CELL ENUMERATION REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

08594208060031

KOMBITEST B/NK Cell 4-color

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagentSingle use

Manufacturer: EXBIO Praha, a.s.
Manufacturer SRN: CZ-MF-000033468
UDI-DI: 08594208060031
Basic UDI-DI: 859420806ED773578
Reference: ED7735
EMDN: W0103080106
EMDN description: ANTIBODIES FOR LYMPHOCYTE SUBTYPING
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

08594208060024

KOMBITEST T Cell 4-color

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagentSingle use

Manufacturer: EXBIO Praha, a.s.
Manufacturer SRN: CZ-MF-000033468
UDI-DI: 08594208060024
Basic UDI-DI: 859420806ED773476
Reference: ED7734
EMDN: W0103080106
EMDN description: ANTIBODIES FOR LYMPHOCYTE SUBTYPING
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

08594208060017

KOMBITEST TBNK 6-color

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagentSingle use

Manufacturer: EXBIO Praha, a.s.
Manufacturer SRN: CZ-MF-000033468
UDI-DI: 08594208060017
Basic UDI-DI: 859420806ED773374
Reference: ED7733
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

06974501891419