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87 device results listed.

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Alinity c Lp(a) Calibrators

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: 00380740153816
Basic UDI-DI: 8436003070467XU
Reference: 01R1401
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:20

Manufacturer products View details

Alinity c A-1-AGP Reagent Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740153793
Basic UDI-DI: 8436003070429XL
Reference: 01R0820
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:20

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Alinity c Digitoxin Standard

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: 00380740153618
Basic UDI-DI: 8436003070610X9
Reference: 01R1101
EMDN: W0102080102
EMDN description: DIGITOXIN
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:20

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Alinity c Proteins Standard

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740151324
Basic UDI-DI: 8436003070443XE
Reference: 08P6701
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:20

Manufacturer products View details

Alinity c β2-Microglobulin Standard

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: 00380740151027
Basic UDI-DI: 8436003070153X2
Reference: 01R0901
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:20

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HemosIL AcuStar VWF:CB

0009802044

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950925743
Basic UDI-DI: 84269509257439V
Reference: 0009802044
EMDN: W0103020218
EMDN description: COAGULATION FACTOR VON WILLEBRAND COLLAGEN BINDING ASSAY (CBA)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:13

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HemosIL HIT- Ab(PF4-H) Controls

HemosIL HIT-Ab(PF4-H)

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950584940
Basic UDI-DI: 8426950584971AK
Reference: 0020013300
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:11

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BIO-FLASH Cuvettes

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950554448
Basic UDI-DI: 84269506397259T
Reference: 3000-8206
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:10

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HemosIL VWF:RCo

0020300900

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950545378
Basic UDI-DI: 84269505453788W
Reference: 0020300900
EMDN: W0103020217
EMDN description: COAGULATION FACTOR VON WILLEBRAND ACTIVITY / RISTOCETIN COFACTOR ACTIVITY (RCO)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:06

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Transferrin

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950507468
Basic UDI-DI: 842695050746882
Reference: 3000-2332
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:05

Manufacturer products View details

rheumajet ASO

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950457305
Basic UDI-DI: 84269504573058F
Reference: 3000-7010
EMDN: W01021105
EMDN description: ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:05

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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