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176 device results listed.

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ACTIVE VITAMIN B12 CONTROL LEVEL 2 (Active Vitamin B12 CONTROL 2)

ACTIVE VITAMIN B12 CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219036
Basic UDI-DI: 50552732BAVB12C173QK
Reference: VB10525
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 16.07.2026 09:46

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Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array

IVD Class CIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220001
Basic UDI-DI: 50552732CTXPLXU068B8
Reference: EV4505
EMDN: -
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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Evidence MultiSTAT Testosterone Control

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219586
Basic UDI-DI: 50552732BTESCON162Q2
Reference: EV4532
EMDN: -
EMDN description: HORMONE CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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Evidence MultiSTAT Testosterone

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219555
Basic UDI-DI: 50552732BTESASS161RM
Reference: EV4513
EMDN: -
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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SERUM BONE MARKER LEVEL 1 CONTROL (SERUM BONE MARKER CONTROL 1)

SERUM BONE MARKER CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219098
Basic UDI-DI: 50552732BSUBOMK154TC
Reference: SBM10574
EMDN: -
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3)

PRE-ECLAMPSIA CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218992
Basic UDI-DI: 50552732CPREECL063JH
Reference: PE10529
EMDN: -
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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ConcizuTrace™ ELISA

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218985
Basic UDI-DI: 50552732CCELISA0649X
Reference: CZM10591
EMDN: -
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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SOLUBLE TRANSFERRIN RECEPTORS CONTROLS (STFR CONTROL)

SOLUBLE TRANSFERRIN RECEPTORS CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215601
Basic UDI-DI: 50552732BSTFCON103QT
Reference: TF10162
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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Ultra-Low PSA Control (UL PSA Control)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218787
Basic UDI-DI: 50552732CULOPSA062XC
Reference: TU10523
EMDN: -
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA CONTROL +)

XANTHOCHROMIA CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218725
Basic UDI-DI: 50552732BXTHPON1553F
Reference: XN10505
EMDN: -
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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BNP CONTROLS FOR BECKMAN (BNP CONTROL)

BNP CONTROLS

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218480
Basic UDI-DI: 50552732CBNPCON061FJ
Reference: CQ10520
EMDN: -
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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TOTAL ANTIOXIDANT STATUS (TAS CONTROL)

TOTAL ANTIOXIDANT STATUS CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204728
Basic UDI-DI: 50552732BTTATSS111Y8
Reference: NX2331
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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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: -
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

Manufacturer products View details

URINE LOW/HIGH CALIBRATORS (ISE CAL U)

URINE LOW/HIGH CALIBRATORS

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215052
Basic UDI-DI: 50552732BURLOCA066SR
Reference: IS2910
EMDN: -
EMDN description: REFERENCE MATERIALS AND BUFFERS (ELECTROLYTES) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

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SERUM LOW/HIGH CALIBRATORS (ISE CAL S)

SERUM LOW/HIGH CALIBRATORS

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215038
Basic UDI-DI: 50552732BSLHCAL174GL
Reference: IS2909
EMDN: -
EMDN description: REFERENCE MATERIALS AND BUFFERS (ELECTROLYTES) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

Manufacturer products View details

URINE LOW OSMOLALITY CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220377
Basic UDI-DI: 50552732BLOOSMC160RD
Reference: UC10650
EMDN: -
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

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Capillary Blood Sample Collection Kit D

IVD Class AIVDR 2017/746On the marketNo EU repKit

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220292
Basic UDI-DI: 50552732ACBSCKD0615C
Reference: SCK10719
EMDN: -
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

Capillary Blood Sample Collection Kit C

VENOUS BLOOD SAMPLE COLLECTION KIT

IVD Class AIVDR 2017/746On the marketNo EU repKit

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220179
Basic UDI-DI: 50552732ACBSCKC06053
Reference: SCK10674
EMDN: -
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

Capillary Blood Sample Collection Kit A

IVD Class AIVDR 2017/746On the marketNo EU repKit

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220155
Basic UDI-DI: 50552732ACBSCKA05852
Reference: SCK10672
EMDN: -
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

Capillary Blood Sample Collection Kit B

IVD Class AIVDR 2017/746On the marketNo EU repKit

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220148
Basic UDI-DI: 50552732ACBSCKB0595B
Reference: SCK10673
EMDN: -
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details