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IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590224028
Basic UDI-DI: 150995901447750LP
Reference: 447750
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Access Sample Diluent A

81908

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221706
Basic UDI-DI: 150995901AccSamDilAP6
Reference: 81908
EMDN: W0102010299
EMDN description: COMPLEMENT COMPONENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

"UniCel DxI Wash Buffer II"

A79784

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590206734
Basic UDI-DI: 150995901DxIWBIIDil7L
Reference: A79784
EMDN: W0102010114
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

"Access Sample Diluent A (Onboard Reagent Kit)"

A79783

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590206727
Basic UDI-DI: 150995901AccSamDilPk29
Reference: A79783
EMDN: W0102010299
EMDN description: COMPLEMENT COMPONENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

"UniCel DxI Access Wash Buffer II"

A16793

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201906
Basic UDI-DI: 150995901DxIWBII5Y
Reference: A16793
EMDN: W0102010114
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180157
Basic UDI-DI: 150995901447700L8
Reference: 447700
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180140
Basic UDI-DI: 150995901447710LB
Reference: 447710
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Urine/CSF Albumin

B46435

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590020422
Basic UDI-DI: 150995902B46435RX
Reference: B46435
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:30

Manufacturer products View details

CRP Latex

OSR6299

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590020392
Basic UDI-DI: 150995901OSR6299N5
Reference: OSR6299
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Urine/CSF Albumin

B38858

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590012076
Basic UDI-DI: 150995902B38858T2
Reference: B38858
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:29

Manufacturer products View details

Ferritin

OSR61203

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590011901
Basic UDI-DI: 150995901OSR61203SK
Reference: OSR61203
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

IgM

OSR61173

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590011598
Basic UDI-DI: 150995901OSR61173T3
Reference: OSR61173
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

IgG

OSR61172

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590011581
Basic UDI-DI: 150995901OSR61172SZ
Reference: OSR61172
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

IgA

OSR61171

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590011574
Basic UDI-DI: 150995901OSR61171SX
Reference: OSR61171
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

RF Latex

OSR61105

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010966
Basic UDI-DI: 150995901OSR61105SJ
Reference: OSR61105
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Latex

OSR6199

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010959
Basic UDI-DI: 150995901OSR6199MY
Reference: OSR6199
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Streptolysin O (ASO)

OSR6194

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010904
Basic UDI-DI: 150995901OSR6194MN
Reference: OSR6194
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Prealbumin

OSR6175

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010706
Basic UDI-DI: 150995901OSR6175MJ
Reference: OSR6175
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin

OSR6168

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

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590010652
Basic UDI-DI: 150995902OSR6168N8
Reference: OSR6168
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:28

Manufacturer products View details

Ceruloplasmin

OSR6164

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010614
Basic UDI-DI: 150995901OSR6164MD
Reference: OSR6164
EMDN: W0102010301
EMDN description: CERULOPLASMIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details