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214 device results listed.

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Immunoglobulin G

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819377
Basic UDI-DI: 6438153BU00109BQ
Reference: 981937
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 16:15

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Immunoglobulin M

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819384
Basic UDI-DI: 6438153BU00110B9
Reference: 981938
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 16:15

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Immunoglobulin A

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819360
Basic UDI-DI: 6438153BU00108BN
Reference: 981936
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 16:15

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CRP

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819339
Basic UDI-DI: 6438153BU00102BA
Reference: 981933
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 16:15

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Complement C4

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819322
Basic UDI-DI: 6438153BU00179CD
Reference: 981932
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Complement C3

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819315
Basic UDI-DI: 6438153BU00178CB
Reference: 981931
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Apolipoprotein B

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819308
Basic UDI-DI: 6438153BU00174C3
Reference: 981930
EMDN: W0102010403
EMDN description: APOLIPOPROTEIN B
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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CK-MB Control

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819087
Basic UDI-DI: 6438153BU00050BG
Reference: 981908
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Pyridoxal Phosphate

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818394
Basic UDI-DI: 6438153BU00164BY
Reference: 981839
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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sCal

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818318
Basic UDI-DI: 6438153BU00055BS
Reference: 981831
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Total Protein Plus

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818271
Basic UDI-DI: 6438153BU00184C6
Reference: 981827
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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uTrol High

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818226
Basic UDI-DI: 6438153BU00049BX
Reference: 981822
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Creatinine (Jaffé)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818103
Basic UDI-DI: 6438153BU00131BH
Reference: 981810
EMDN: W01010207
EMDN description: CREATININE
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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SpeciTrol High

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817991
Basic UDI-DI: 6438153BU00170BT
Reference: 981799
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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CRP High Sensitivity

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817984
Basic UDI-DI: 6438153BU00060BK
Reference: 981798
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Uric Acid (AOX)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817885
Basic UDI-DI: 6438153BU00186CA
Reference: 981788
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Triglycerides

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817861
Basic UDI-DI: 6438153BU00147BY
Reference: 981786
EMDN: W01010231
EMDN description: TRIGLYCERIDES
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Albumin (BCG)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817670
Basic UDI-DI: 6438153BU00151BP
Reference: 981767
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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HbA1c Control Normal

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816956
Basic UDI-DI: 6438153BU00026BK
Reference: 981695
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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CRP Control High

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816796
Basic UDI-DI: 6438153BU00105BG
Reference: 981679
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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