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83 device results listed.

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Lp(a)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950345107
Basic UDI-DI: 842695034510773
Reference: 3000-2292
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:04

Manufacturer products View details

Proteins Calibrators

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950345015
Basic UDI-DI: 84269503450156V
Reference: 3000-2128
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:04

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IgG

3000-2269

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950036951
Basic UDI-DI: 842695003695173
Reference: 3000-2269
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:03

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IgA

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950036944
Basic UDI-DI: 842695003694476
Reference: 3000-2268
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:03

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RF plus Calibrator

RF (II)

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950013204
Basic UDI-DI: 84269505424768A
Reference: 3000-2252
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:02

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IgM

3000-2270

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950013006
Basic UDI-DI: 842695001300646
Reference: 3000-2270
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:02

Manufacturer products View details

monogen kit 50 tests

Monogen

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950001676
Basic UDI-DI: 84269500016764Y
Reference: 3000-1001
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:02

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HemosIL FDP Controls

HemosIL FDP

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950581918
Basic UDI-DI: 8426950581895A7
Reference: 0020009920
EMDN: W0103020502
EMDN description: FIBRINOGEN DEGRADATION PRODUCTS
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:24

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HemosIL FDP Calibrator

HemosIL FDP

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950581901
Basic UDI-DI: 8426950581895A7
Reference: 0020009910
EMDN: W0103020502
EMDN description: FIBRINOGEN DEGRADATION PRODUCTS
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:24

Manufacturer products View details

HemosIL FDP

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950581895
Basic UDI-DI: 8426950581895A7
Reference: 0020009900
EMDN: W0103020502
EMDN description: FIBRINOGEN DEGRADATION PRODUCTS
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:24

Manufacturer products View details

CRP plus

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950041924
Basic UDI-DI: 842695004192468
Reference: 3000-2209
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:23

Manufacturer products View details

CRP plus Calibrator

CRP plus

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950036975
Basic UDI-DI: 842695004192468
Reference: 3000-2093
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:22

Manufacturer products View details

Alinity c β2-Microglobulin Reagent Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740153595
Basic UDI-DI: 8436003070153X2
Reference: 01R0920
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

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Alinity c Digitoxin Controls

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740153625
Basic UDI-DI: 8436003070610X9
Reference: 01R1110
EMDN: W0102080102
EMDN description: DIGITOXIN
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

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Alinity c Digitoxin Reagent Kit

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740153632
Basic UDI-DI: 8436003070610X9
Reference: 01R1122
EMDN: W0102080102
EMDN description: DIGITOXIN
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

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Alinity c Myoglobin Standard

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740153779
Basic UDI-DI: 8436003070498Y7
Reference: 01R1501
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

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Alinity c Lp(a) Control Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740153823
Basic UDI-DI: 8436003070467XU
Reference: 01R1410
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

Manufacturer products View details

Alinity c Lp(a) Reagent Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740153830
Basic UDI-DI: 8436003070467XU
Reference: 01R1420
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

Manufacturer products View details

Quantia β2-Microglobulin Standard

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740157326
Basic UDI-DI: 8436003070139X8
Reference: 6K47-03
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

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Lp(a) Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740157449
Basic UDI-DI: 8436003070290XD
Reference: 5P84-11
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

Manufacturer products View details