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108 device results listed.

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VALIDATE® TDM1 Test Set

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005036
Basic UDI-DI: B-00859110005036
Reference: 301db
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® TDM1 Test Set

301au

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005012
Basic UDI-DI: B-00859110005012
Reference: 301au
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® TDM1 Test Set

301ab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005005
Basic UDI-DI: B-00859110005005
Reference: 301ab
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Lacosamide Control

5033-0003-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003353
Basic UDI-DI: B-00858724003353
Reference: 5033-0003-00
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
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 Control

5030-0003-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003247
Basic UDI-DI: B-00858724003247
Reference: 5030-0003-01
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
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 Topiramate Control

5015-0003-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003124
Basic UDI-DI: B-00858724003124
Reference: 5015-0003-00
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
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

VALIDATE® Immunosuppressants

608mm

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00850011135396
Basic UDI-DI: B-00850011135396
Reference: 608mm
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

00380740101220

5P04-21

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00380740101220
Basic UDI-DI: B-00380740101220
Reference: 5P04-21
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Thermo Fisher Scientific Oy
Last updated: 04.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Cyclosporine (CLIA) Controls

Cyclosporine (CLIA) Controls

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145586171
Basic UDI-DI: 694714551046J4
Reference: 1602011046MT
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Tacrolimus (CLIA) Controls

Tacrolimus (CLIA) Controls

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145580605
Basic UDI-DI: 69471455485WV
Reference: 1602011036MT
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNO-TROL i-Tracker Anti-Infliximab Total Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001537
Basic UDI-DI: 353267CTI003TPCA65
Reference: CTI 003T-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Anti-Adalimumab Total Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001520
Basic UDI-DI: 353267CTA003TPCAZA
Reference: CTA 003T-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Anti-Ocrelizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000479
Basic UDI-DI: 353267CTO003PCAX5
Reference: CTO 003-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Ocrelizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000462
Basic UDI-DI: 353267CTO002PCAWW
Reference: CTO 002-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Anti-Risankizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000431
Basic UDI-DI: 353267CTRZ003PCAR8
Reference: CTRZ 003-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Risankizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000424
Basic UDI-DI: 353267CTRZ002PCAQZ
Reference: CTRZ 002-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Anti-Etanercept

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000370
Basic UDI-DI: 353267CTE003PCART
Reference: CTE 003-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

IMMUNO-TROL i-Tracker Etanercept

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000363
Basic UDI-DI: 353267CTE002PCARL
Reference: CTE 002-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

N aTNFa Controls ETA

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414615509
Basic UDI-DI: 0405686902180VE
Reference: 10873744
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 22:55

Manufacturer products View details

N aTNFa Controls INF

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414615424
Basic UDI-DI: 0405686902180VE
Reference: 10873742
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 22:55

Manufacturer products View details