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CUSTOM LIQUID IMMUNOASSAY CONTROL - LEVEL 1

CUSTOM LIQUID IMMUNOASSAY CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217513
Basic UDI-DI: 50552732BLIC123180MW
Reference: LIA3148
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

CUSTOM LIQUID THERAPEUTIC DRUG CONTROL - LEVEL 1

CUSTOM LIQUID THERAPEUTIC DRUG CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217315
Basic UDI-DI: 50552732BLTDCON177KM
Reference: HD3145
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

CARDIAC CONTROL - ULTRA LOW (CRD CONTROL Ultra Low)

CARDIAC CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217117
Basic UDI-DI: 50552732BCRDCON001AS
Reference: CQ10453
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

CUSTOM LIQUID SPECIFIC PROTEIN CONTROL - LEVEL 1

CUSTOM LIQUID SPECIFIC PROTEIN CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216615
Basic UDI-DI: 50552732BLSPC1218199
Reference: PS3151
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL)

SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215557
Basic UDI-DI: 50552732BSTFCAL104KM
Reference: TF10161
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1)

PARATHYROID HORMONE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215328
Basic UDI-DI: 50552732BPHCLLC090EN
Reference: PTH10110
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1)

APOLIPOPROTEIN CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273209105
Basic UDI-DI: 50552732BAPOCON016EE
Reference: LE5016
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

ETHANOL CALIBRATOR AND CONTROL SET (EtOH CAL/ CONTROL)

ETHANOL CALIBRATOR AND CONTROL SET

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273207873
Basic UDI-DI: 50552732BETHCON051FZ
Reference: DA2703
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3)

LIPOPROTEIN (a) CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204445
Basic UDI-DI: 50552732BLIPCON082K4
Reference: LP3406
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

LIPOPROTEIN (a) CALIBRATOR SERIES (Lp(a) CAL SET)

LIPOPROTEIN (a) CALIBRATOR SERIES

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204438
Basic UDI-DI: 50552732BLCALSS081DM
Reference: LP3404
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

APOLIPOPROTEIN CALIBRATOR (APO CAL)

APOLIPOPROTEIN CALIBRATOR

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204414
Basic UDI-DI: 50552732BAPOCAL01594
Reference: LP3023
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG CAL)

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204056
Basic UDI-DI: 50552732BILPCAL107D7
Reference: IT3861
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

LIQUID PROTEIN CALIBRATORS (SP CAL (LIQ))

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204049
Basic UDI-DI: 50552732BLUPCAL106LM
Reference: IT2692
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

μTASWako DCP Calibrator Set

995-60701, 999-61201, 995-61301, 991-61401

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164475
Basic UDI-DI: 49874814987481164413UA
Reference: 999-61201
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako AFP-L3 Calibrator Set

999-60601, 997-60901, 997-61001, 993-61101

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164437
Basic UDI-DI: 49874814987481164390UP
Reference: 997-60901
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

α1-Microglobulin Calibrator Set

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Denka Co., Ltd.
Manufacturer SRN: JP-MF-000015952
UDI-DI: 04987503610102
Basic UDI-DI: 4987503A1MGUcal6J
Reference: 08944474190
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

FIT Hb/Tf Liquid Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274139383
Basic UDI-DI: 4987274W01021521HTC012K
Reference: 913938
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

NESCAUTO Cp Auto Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274126840
Basic UDI-DI: 4987274W0102152203CPS00Y4
Reference: 912684
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

NESCAUTO Cp Auto Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274126833
Basic UDI-DI: 4987274W0102152003CPC00UE
Reference: 912683
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

FIT NS-Prime Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274108730
Basic UDI-DI: 4987274W01021521HTC002H
Reference: 910873
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details