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83 device results listed.

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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

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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

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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

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Quantia Ferritin Standard

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740157463
Basic UDI-DI: 8436003070115WS
Reference: 6K49-03
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

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Quantia Lp(a)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740157494
Basic UDI-DI: 8436003070290XD
Reference: 7K00-03
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

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Quantia Digitoxin Standard

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740157531
Basic UDI-DI: 8436003070573XU
Reference: 6K48-02
EMDN: W0102080102
EMDN description: DIGITOXIN
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

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Quantia Digitoxin Control

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740157555
Basic UDI-DI: 8436003070573XU
Reference: 6K57-02
EMDN: W0102080102
EMDN description: DIGITOXIN
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 18:13

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RF(II)

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950542476
Basic UDI-DI: 84269505424768A
Reference: 3000-2333
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:01

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BIO-FLASH Triggers

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950554455
Basic UDI-DI: 84269506397259T
Reference: 3000-8204
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:01

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BIO-FLASH System Rinse

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950554462
Basic UDI-DI: 84269506397259T
Reference: 3000-8205
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:01

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BIO-FLASH Sample Cups

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950554479
Basic UDI-DI: 84269506397259T
Reference: 3000-8209
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:01

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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: 08426950584971
Basic UDI-DI: 8426950584971AK
Reference: 0020302700
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:01

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monogen kit 150 tests

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950585350
Basic UDI-DI: 84269500016764Y
Reference: 3000-1002
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:01

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Lp(a) Calibrators

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950587781
Basic UDI-DI: 842695034510773
Reference: 3000-2342
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:01

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Lp(a) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950587798
Basic UDI-DI: 842695034510773
Reference: 3000-2343
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:01

Manufacturer products View details

BIO-FLASH Sample Diluent

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950589433
Basic UDI-DI: 84269506397259T
Reference: 3000-8207
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:01

Manufacturer products View details