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IMMAGE Immunochemistry Systems UDR

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590223359
Basic UDI-DI: 150995901447250KW
Reference: 447250
EMDN: W05030199
EMDN description: SAMPLES ANALYSES, CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221225
Basic UDI-DI: 150995901447460LB
Reference: 447460
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221218
Basic UDI-DI: 150995901447470LE
Reference: 447470
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems ALB Albumin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221201
Basic UDI-DI: 150995901447600L3
Reference: 447600
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221195
Basic UDI-DI: 150995901447610L6
Reference: 447610
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems ASO Anti-Streptolysin O Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221188
Basic UDI-DI: 150995901447620L9
Reference: 447620
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221171
Basic UDI-DI: 150995901447450L8
Reference: 447450
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems TRF Transferrin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180171
Basic UDI-DI: 150995901447630LC
Reference: 447630
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems MA Microalbumin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180164
Basic UDI-DI: 150995901447690LW
Reference: 447690
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

Ultimate-D Bilirubin Control Level 4

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-667740S7
Basic UDI-DI: B-667740S7
Reference: 667740
EMDN: W0101050203
EMDN description: BILIRUBIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

Ultimate-D Bilirubin Control Level 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-667730S4
Basic UDI-DI: B-667730S4
Reference: 667730
EMDN: W0101050203
EMDN description: BILIRUBIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

Ultimate-D Bilirubin Control Level 2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-667720RZ
Basic UDI-DI: B-667720RZ
Reference: 667720
EMDN: W0101050203
EMDN description: BILIRUBIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

Ultimate-D Bilirubin Control Level 1

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-667710RW
Basic UDI-DI: B-667710RW
Reference: 667710
EMDN: W0101050203
EMDN description: BILIRUBIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

CLENZ Solution

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-664090QW
Basic UDI-DI: B-664090QW
Reference: 664090
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 2 Calibrator 2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-663940RM
Basic UDI-DI: B-663940RM
Reference: 663940
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

LeukoSure Fluorospheres

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-6607124ZC
Basic UDI-DI: B-6607124ZC
Reference: 6607124
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNO-TROL Low Cells

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-660709827
Basic UDI-DI: B-660709827
Reference: 6607098
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNO-TROL Cells

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-6607077ZU
Basic UDI-DI: B-6607077ZU
Reference: 6607077
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-6607073ZL
Basic UDI-DI: B-6607073ZL
Reference: 6607073
EMDN: W0103080106
EMDN description: ANTIBODIES FOR LYMPHOCYTE SUBTYPING
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

CYTO-STAT triCHROME CD45-FITC/CD19-RD1 ICD3-PC5

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-6607072ZJ
Basic UDI-DI: B-6607072ZJ
Reference: 6607072
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details