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Access HBc IgM Calibrators

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34255GE
Basic UDI-DI: B-34255GE
Reference: 34255
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBc IgM (Reagent Pack)

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34250G4
Basic UDI-DI: B-34250G4
Reference: 34250
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

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Access HBc Ab QC

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34249GK
Basic UDI-DI: B-34249GK
Reference: 34249
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBc Ab Calibrators

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34245GB
Basic UDI-DI: B-34245GB
Reference: 34245
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBc Ab

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34240FZ
Basic UDI-DI: B-34240FZ
Reference: 34240
EMDN: W0105020202
EMDN description: HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

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Access HAV IgM QC

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34219GA
Basic UDI-DI: B-34219GA
Reference: 34219
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access HAV IgM Calibrators

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34215G2
Basic UDI-DI: B-34215G2
Reference: 34215
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access HAV IgM (Reagent Pack)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34210FQ
Basic UDI-DI: B-34210FQ
Reference: 34210
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

HAV Ab QC

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34209G7
Basic UDI-DI: B-34209G7
Reference: 34209
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

HAV Ab Calibrators

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34205FX
Basic UDI-DI: B-34205FX
Reference: 34205
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

HAV Ab (Reagent pack)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34200FM
Basic UDI-DI: B-34200FM
Reference: 34200
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access Digoxin Calibrator S0

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33716GN
Basic UDI-DI: B-33716GN
Reference: 33716
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Access Digoxin Calibrators

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33715GL
Basic UDI-DI: B-33715GL
Reference: 33715
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Access Digoxin (reagent pack)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33710GA
Basic UDI-DI: B-33710GA
Reference: 33710
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Access CEA QC

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33209FY
Basic UDI-DI: B-33209FY
Reference: 33209
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Access CEA Diluent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33206FS
Basic UDI-DI: B-33206FS
Reference: 33206
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Access CEA Calibrators

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33205FQ
Basic UDI-DI: B-33205FQ
Reference: 33205
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Access CEA (Reagent Pack)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33200FE
Basic UDI-DI: B-33200FE
Reference: 33200
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER S-CAL Calibrator Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-179310Q2
Basic UDI-DI: B-179310Q2
Reference: 179310
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
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 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