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LeukoSure Enumeration Kit

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-PartNumber17562129
Basic UDI-DI: B-PartNumber17562129
Reference: 175621
EMDN: W0103080499
EMDN description: FLOW CYTOMETRY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 15.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

spinit®

spinit® BC control

IVD generalIVDDOn the marketHuman tissuesNear-patient testingProfessional testingReagent

Manufacturer: biosurfit SA
Manufacturer SRN: PT-MF-000033920
UDI-DI: D-910201P3
Basic UDI-DI: B-910201P3
Reference: 910201
EMDN: W0103080402
EMDN description: LEUCOCYTE CONTROLS
First on market country: Portugal
Authorised representative: -
Last updated: 12.07.2026 20:55

Manufacturer products View details

Flow-Count Fluorospheres

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-75470532Z
Basic UDI-DI: B-75470532Z
Reference: 7547053
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

PC7 (770/488) SETUP KIT

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-737664RU
Basic UDI-DI: B-737664RU
Reference: 737664
EMDN: W0103080401
EMDN description: SETUP BEADS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

APC (675/633) Setup Kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-737663RS
Basic UDI-DI: B-737663RS
Reference: 737663
EMDN: W0103080401
EMDN description: SETUP BEADS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

IOTest MslgG1-PC7

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-737662RQ
Basic UDI-DI: B-737662RQ
Reference: 737662
EMDN: W0103080499
EMDN description: FLOW CYTOMETRY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

IOTest CD8-PC7

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-737661RN
Basic UDI-DI: B-737661RN
Reference: 737661
EMDN: W0103080199
EMDN description: MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

IOTest CD4-PC7

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-737660RL
Basic UDI-DI: B-737660RL
Reference: 737660
EMDN: W0103080199
EMDN description: MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

CYTO-STAT/COULTER CLONE CD8-ECD

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-737659S3
Basic UDI-DI: B-737659S3
Reference: 737659
EMDN: W0103080199
EMDN description: MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

IOTest CD3-PC7

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-737657RX
Basic UDI-DI: B-737657RX
Reference: 737657
EMDN: W0103080199
EMDN description: MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

QuickComp 2 Kit

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-177018PM
Basic UDI-DI: B-177018PM
Reference: 177018
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

QuickComp 4 Kit

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-177017PK
Basic UDI-DI: B-177017PK
Reference: 177017
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

Leuko-Trol RBC Control Cells

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-175658QH
Basic UDI-DI: B-175658QH
Reference: 175658
EMDN: W0103080499
EMDN description: FLOW CYTOMETRY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

Leuko-Trol Platelet Control Cells

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-175651Q3
Basic UDI-DI: B-175651Q3
Reference: 175651
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

VISITECT

AB376

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: AccuBio Limited
Manufacturer SRN: UK-MF-000041152
UDI-DI: 15061002300019
Basic UDI-DI: B-15061002300019
Reference: AB376
EMDN: W0103080106
EMDN description: ANTIBODIES FOR LYMPHOCYTE SUBTYPING
First on market country: -
Authorised representative: Advena Limited
Last updated: 11.07.2026 08:33

Manufacturer products Authorised representative products Authorised representative actors View details

FIX&PERM® Kit 1000 Cell Fixation and Permeabilization kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Vector Laboratories, Inc.
Manufacturer SRN: US-MF-000057003
UDI-DI: 00860015684516
Basic UDI-DI: 08600156845FIXPERMCEIVDRQ
Reference: GAS-002-1-CE/IVD
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 09.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

FIX&PERM® Sample Kit Cell Fixation and Permeabilization kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Vector Laboratories, Inc.
Manufacturer SRN: US-MF-000057003
UDI-DI: 00860015684547
Basic UDI-DI: 08600156845FIXPERMCEIVDRQ
Reference: GAS-002M-CE/IVD
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 09.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

FIX&PERM® Solution A (Fix) Cell Fixation and Permeabilization kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Vector Laboratories, Inc.
Manufacturer SRN: US-MF-000057003
UDI-DI: 00860015684523
Basic UDI-DI: 08600156845FIXPERMCEIVDRQ
Reference: GAS-002A-1-CE/IVD
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 09.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin A Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555622495
Basic UDI-DI: B-08683555622495
Reference: B45190
EMDN: W0103080202
EMDN description: IGA, IGD, IGM, IGG, IGE
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:53

Manufacturer products View details

Immunoglobulin M Kit

Immunoglobulin M Kit 50mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555619020
Basic UDI-DI: B-08683555619020
Reference: B28206
EMDN: W0103080202
EMDN description: IGA, IGD, IGM, IGG, IGE
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:50

Manufacturer products View details