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SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-441350NU
Basic UDI-DI: B-441350NU
Reference: 441350
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

Direct Bilirubin Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-439715QT
Basic UDI-DI: B-439715QT
Reference: 439715
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Ammonia Reagent (AMM 2 x 25)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-439770R3
Basic UDI-DI: B-439770R3
Reference: 439770
EMDN: W01010301
EMDN description: AMMONIA
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Salicylate Reagent (SALY 2 x 45)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-378194RB
Basic UDI-DI: B-378194RB
Reference: 378194
EMDN: W0102090213
EMDN description: SALICYLATE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Vancomycin Calibrator

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-378045QR
Basic UDI-DI: B-378045QR
Reference: 378045
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-378020Q9
Basic UDI-DI: B-378020Q9
Reference: 378020
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 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgM II QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34479H6
Basic UDI-DI: B-34479H6
Reference: 34479
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgM II Calibrators

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34475GW
Basic UDI-DI: B-34475GW
Reference: 34475
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 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgM II

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34470GL
Basic UDI-DI: B-34470GL
Reference: 34470
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access RUBELLA IgM QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34449GV
Basic UDI-DI: B-34449GV
Reference: 34449
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access RUBELLA IgM CALIBRATORS

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34445GM
Basic UDI-DI: B-34445GM
Reference: 34445
EMDN: W0105080904
EMDN description: OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access RUBELLA IgG QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34439GS
Basic UDI-DI: B-34439GS
Reference: 34439
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 Rubella IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34430G8
Basic UDI-DI: B-34430G8
Reference: 34430
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
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 QC

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34259GN
Basic UDI-DI: B-34259GN
Reference: 34259
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 RUBELLA IgG Calibrators

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34435GJ
Basic UDI-DI: B-34435GJ
Reference: 34435
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 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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details