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75 device results listed.

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Biocard™ Celiac Home

3-028-200

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842928015
Basic UDI-DI: B-06416842928015
Reference: 3-028-200
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:48

Manufacturer products View details

Biocard™ H pylori IgG Home

3-018-200

IVD self-testing devicesIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842918030
Basic UDI-DI: B-06416842918030
Reference: 3-018-200
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

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Blocard ™ Celiac Test

Biocard Celiac Test

IVD generalIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842828018
Basic UDI-DI: B-06416842828018
Reference: 3-028-000
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

Manufacturer products View details

Biocard Helicobacter pylori IgG

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842818019
Basic UDI-DI: B-06416842818019
Reference: 3-018-110
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

Manufacturer products View details

Biocard™ Helicobacter pylori Urease

Biocard Helicobacter pylori Urease test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842618015
Basic UDI-DI: B-06416842618015
Reference: 3-018-945
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

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Biocard Mycoplasma pneumoniae IgM

3-035-000

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842035010
Basic UDI-DI: B-06416842035010
Reference: 3-035-000
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

Manufacturer products View details

Biocard Chlamydia pneumoniae IgM

IVD Annex II List BIVDDOn the marketKitNear-patient testingProfessional testingReagentSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842034013
Basic UDI-DI: B-06416842034013
Reference: 3-034-000
EMDN: W0105010116
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGM
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

Manufacturer products View details

NS96 Disc Remover

5550300

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172555013
Basic UDI-DI: 6438172555I0001TR
Reference: 5550400
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NS Washer

5410100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172550018
Basic UDI-DI: 6438172551I0001S5
Reference: 5410100
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NS496 Plus

5450300

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172540019
Basic UDI-DI: 6438172540I0001R7
Reference: 5450300
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NS Reader

5420100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172530010
Basic UDI-DI: 6438172532I0001RG
Reference: 5420100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NS2400

5400200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172520011
Basic UDI-DI: 6438172520I0001Q5
Reference: 5400200
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NS96 Disc Remover

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172555020
Basic UDI-DI: 6438172555I0001TR
Reference: 5550300
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:41

Manufacturer products View details

VAE-Extraction Solution with Internal Standards