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CAL 5 PLUS Calibrator 5 Plus

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469975SQ
Basic UDI-DI: B-469975SQ
Reference: 469975
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
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

SYNCHRON Systems Drug Calibrator 2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469630RK
Basic UDI-DI: B-469630RK
Reference: 469630
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 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Drug Calibrator 1

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469600RA
Basic UDI-DI: B-469600RA
Reference: 469600
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 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

APO CAL Apolipoprotein Calibrator

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469283RL
Basic UDI-DI: B-469283RL
Reference: 469283
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
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

SYNCHRON Systems APO Calibrator

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469170R6
Basic UDI-DI: B-469170R6
Reference: 469170
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 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-468429RH
Basic UDI-DI: B-468429RH
Reference: 468429
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 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465365QT
Basic UDI-DI: B-465365QT
Reference: 465365
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 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 20 ng/mL THC Urine Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-464390QK
Basic UDI-DI: B-464390QK
Reference: 464390
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 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Protein Calibrator Levels 1 and 2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450202NG
Basic UDI-DI: B-450202NG
Reference: 450202
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 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 3 Calibrator 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-449730R2
Basic UDI-DI: B-449730R2
Reference: 449730
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 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 1 Calibrator 1

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-449560QZ
Basic UDI-DI: B-449560QZ
Reference: 449560
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 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 200 ng/mL THC Urine Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-445814QD
Basic UDI-DI: B-445814QD
Reference: 445814
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 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 100 ng/mL THC Urine Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-445811Q7
Basic UDI-DI: B-445811Q7
Reference: 445811
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 50 ng/mL THC Urine Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-445809QL
Basic UDI-DI: B-445809QL
Reference: 445809
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 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems DAT Negative Urine Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-445803Q8
Basic UDI-DI: B-445803Q8
Reference: 445803
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 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems UCAL Urine Protein Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-441470P7
Basic UDI-DI: B-441470P7
Reference: 441470
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 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

Antimycotic Medication Reagent Set

4280 P AMM

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4280PAMMMR
Basic UDI-DI: B-4280PAMMMR
Reference: 4280 P AMM
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:44

Manufacturer products View details

Benzodiazepines Reagent Set

4240 P BZD

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4240PBZDLX
Basic UDI-DI: B-4240PBZDLX
Reference: 4240 P BZD
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:16

Manufacturer products View details

Nortriptyline Reagent Set

4140 P NTP

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4140PNTPNG
Basic UDI-DI: B-4140PNTPNG
Reference: 4140 P NTP
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:08

Manufacturer products View details

Clozapine Reagent Set

4120 P CZP

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4120PCZPLH
Basic UDI-DI: B-4120PCZPLH
Reference: 4120 P CZP
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:08

Manufacturer products View details