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SYNCHRON Systems DAT Multi-Drug Low Urine Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474976S2
Basic UDI-DI: B-474976S2
Reference: 474976
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

VigilTM TDM Control level 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472472QK
Basic UDI-DI: B-472472QK
Reference: 472472
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

VigilTM TDM Control level 2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472467QS
Basic UDI-DI: B-472467QS
Reference: 472467
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

VigilTM TDM Control level 1

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472461QE
Basic UDI-DI: B-472461QE
Reference: 472461
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 40 ng/mL THC Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472110PE
Basic UDI-DI: B-472110PE
Reference: 472110
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 10 ng/mL THC Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472107PR
Basic UDI-DI: B-472107PR
Reference: 472107
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems DAT Drug Free Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469945SF
Basic UDI-DI: B-469945SF
Reference: 469945
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil™ Lipid Control Level 1

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469905S3
Basic UDI-DI: B-469905S3
Reference: 469905
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil™ Lipid Control Level 4

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465982RR
Basic UDI-DI: B-465982RR
Reference: 465982
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil™ Lipid Control Level 3

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465981RP
Basic UDI-DI: B-465981RP
Reference: 465981
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil™ Lipid Control Level 2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465980RM
Basic UDI-DI: B-465980RM
Reference: 465980
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 125 ng/mL THC Urine Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465939RQ
Basic UDI-DI: B-465939RQ
Reference: 465939
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 20 ng/mL THC Urine Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465914R8
Basic UDI-DI: B-465914R8
Reference: 465914
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 75 ng/mL THC Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465912R4
Basic UDI-DI: B-465912R4
Reference: 465912
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems Level 2 Urine Protein Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465300PX
Basic UDI-DI: B-465300PX
Reference: 465300
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems Level 1 Urine Protein Control

IVD generalIVDDOn the marketHuman tissuesReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465290QM
Basic UDI-DI: B-465290QM
Reference: 465290
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450164NZ
Basic UDI-DI: B-450164NZ
Reference: 450164
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450163NX
Basic UDI-DI: B-450163NX
Reference: 450163
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 1

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450162NV
Basic UDI-DI: B-450162NV
Reference: 450162
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Protein Control Level 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450130NG
Basic UDI-DI: B-450130NG
Reference: 450130
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details