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216 device results listed.

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ABX Pentra CRP Cal

A11A01616

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004821
Basic UDI-DI: 361023pentra_crp_calMN
Reference: A11A01616
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

Manufacturer products View details

ABX Pentra CRP CP

A11A01611

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004791
Basic UDI-DI: 361023pentra_crpBF
Reference: A11A01611
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

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Whitediff 1L

1210906022

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004746
Basic UDI-DI: 361023whitediff4Z
Reference: 1210906022
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

Manufacturer products View details

ABX CRP Trol I

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009772
Basic UDI-DI: 361023crp_trol62
Reference: 3201054580
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

ESRtrol

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009543
Basic UDI-DI: 361023esrtrolQA
Reference: 1300128293
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

Atellica HEMA 530

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009536
Basic UDI-DI: 361023at_530GF
Reference: 1300128174
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

Atellica HEMA 520 CT

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009529
Basic UDI-DI: 361023at_520_ct5U
Reference: 1300128173
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

Atellica HEMA 520 OT

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009512
Basic UDI-DI: 361023at_520_ot6Y
Reference: 1300128171
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

ABX Minotrol Retic

2072201, 2072202, 1300136023, 1300136026, 1300136029

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008898
Basic UDI-DI: 361023minotrol_reticB2
Reference: 2072201, 2072202, 1300136023, 1300136026, 1300136029
EMDN: W0103010506
EMDN description: RETICULOCYTE CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

ABX Minotrol CRP

2042205, 2042206, 2042206

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008812
Basic UDI-DI: 361023minotrol_crpUQ
Reference: 1212042205
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

BFTROL

1300039405

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008584
Basic UDI-DI: 361023bftrolZF
Reference: 1300039405
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

ABX Minocal

2032002

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008577
Basic UDI-DI: 361023minocalJC
Reference: 1212032002
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

ABX Difftrol

2062207

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008546
Basic UDI-DI: 361023difftrolXR
Reference: 2062207
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

ABX Minotrol 16

2042202

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008515
Basic UDI-DI: 361023minotrol16BH
Reference: 1212042208
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

Nucediff 1L

1300027030

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008157
Basic UDI-DI: 361023nucediff4G
Reference: 1300027030
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

ISE Module Complete Pentra C400

1280060004

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005927
Basic UDI-DI: 361023ise_pentra_c4008D
Reference: 1280060004
EMDN: W0101070199
EMDN description: ELECTROLYTE ELECTRODES - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

CUVETTES RACK PENTRA C200

A11A01914

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005644
Basic UDI-DI: 361023cuvette_rackPM
Reference: A11A01914
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

CUVETTE SEGMENTS

A11A01891

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005583
Basic UDI-DI: 361023cuvette_segmentsDE
Reference: A11A01891
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

Minilysebio 0.4L

0906020

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004722
Basic UDI-DI: 361023minilysebioVG
Reference: 0906020
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

ABX Lysebio 1L

0906012

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004685
Basic UDI-DI: 361023lysebioQM
Reference: 0906012
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details