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59 device results listed.

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Psychotropic Medication 2 Reagent Set

4070 P PS2

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4070PPS2MK
Basic UDI-DI: B-4070PPS2MK
Reference: 4070 P PS2
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:07

Manufacturer products 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

Voriconazole Control

2Levels×1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081238
Basic UDI-DI: B-06978945081238
Reference: LBZK907A
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View details

Clozapine/Aripiprazole/Risperidone/Olanzapine Control

2 Levels×1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081214
Basic UDI-DI: B-06978945081214
Reference: LBZK909A
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View details

Immune Inhibitor Control

2 Levels×1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081160
Basic UDI-DI: B-06978945081160
Reference: LBZK902A
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View details

00884883008977

08P6801

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883008977
Basic UDI-DI: B-00884883008977
Reference: 08P6801
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

00884883008960

08P6802

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883008960
Basic UDI-DI: B-00884883008960
Reference: 08P6802
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

00884883008953

08P6810

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883008953
Basic UDI-DI: B-00884883008953
Reference: 08P6810
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Lacosamide Calibrator

5033-0002-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003346
Basic UDI-DI: B-00858724003346
Reference: 5033-0002-00
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Voriconazole II Calibrator

5030-0002-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003230
Basic UDI-DI: B-00858724003230
Reference: 5030-0002-01
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Topiramate Calibrator

5015-0002-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003063
Basic UDI-DI: B-00858724003063
Reference: 5015-0002-00
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Digoxin Calibrator

ODC6404

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070496
Basic UDI-DI: 150995902ODC6404AM
Reference: ODC6404
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:45

Manufacturer products View details

DAU Intermediate Multi-Drug Calibrator

ODC6317

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070168
Basic UDI-DI: 150995902ODC6317AR
Reference: ODC6317
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:44

Manufacturer products View details

DAU High Multi-Drug Calibrator

ODC6318

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070175
Basic UDI-DI: 150995902ODC6318AT
Reference: ODC6318
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:44

Manufacturer products View details

DAU Secondary cut-off Multi-Drug Calibrator

ODC6316

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070151
Basic UDI-DI: 150995902ODC6316AP
Reference: ODC6316
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:44

Manufacturer products View details

DAU Negative Calibrator

ODC6314

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070137
Basic UDI-DI: 150995902ODC6314AK
Reference: ODC6314
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:44

Manufacturer products View details

N aTNFa Standard ETA

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414615493
Basic UDI-DI: 0405686902179VV
Reference: 10873743
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 22:55

Manufacturer products View details

N aTNFa Standard INF

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414615417
Basic UDI-DI: 0405686902179VV
Reference: 10873741
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 22:55

Manufacturer products View details

ETHANOL CALIBRATOR

IVD generalNot specifiedOn the market

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309077885
Basic UDI-DI: B-05204309077885
Reference: 1478-1120
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: -
Last updated: 20.06.2026 03:15

Manufacturer products View details