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Active filter:Manufacturer SRN:FI-MF-000024114

25 device results listed.

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GenomEra® S. pneumoniae Assay Kit

CDX-70

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-70-01-40VW
Basic UDI-DI: B-CDX-70-01-40VW
Reference: CDX-70-01-40
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

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GenomEra® S. pneumoniae Assay Kit

CDX-70

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-70-01-20VQ
Basic UDI-DI: B-CDX-70-01-20VQ
Reference: CDX-70-01-20
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

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GenomEra® GBS Assay Kit

CDX-60

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-60-01-40VB
Basic UDI-DI: B-CDX-60-01-40VB
Reference: CDX-60-01-40
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

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GenomEra® GBS Assay Kit

CDX-60

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-60-01-20V5
Basic UDI-DI: B-CDX-60-01-20V5
Reference: CDX-60-01-20
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

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GenomEra® C. difficile Assay Kit

CDX-40

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-40-02-40UC
Basic UDI-DI: B-CDX-40-02-40UC
Reference: CDX-40-02-40
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

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GenomEra® C. difficile Assay Kit

CDX-40

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-40-01-40U5
Basic UDI-DI: B-CDX-40-01-40U5
Reference: CDX-40-01-40
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

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GenomEra® C. difficile Assay Kit

CDX-40

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-40-01-20TX
Basic UDI-DI: B-CDX-40-01-20TX
Reference: CDX-40-01-20
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

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GenomEra® MRSA/SA AC Assay Kit

CDX-30-05

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-30-05-40UE
Basic UDI-DI: B-CDX-30-05-40UE
Reference: CDX-30-05-40
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

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GenomEra® MRSA/SA AC Assay Kit

CDX-30-05

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-30-05-20U8
Basic UDI-DI: B-CDX-30-05-20U8
Reference: CDX-30-05-20
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra® MRSA/SA Multi Swab Assay Kit

CDX-30-02

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-30-02-20TK
Basic UDI-DI: B-CDX-30-02-20TK
Reference: CDX-30-02-20
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra® C. difficile Control Set

CDX-20-561

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-20-561BT
Basic UDI-DI: B-CDX-20-561BT
Reference: CDX-20-561
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra HSV 1/2, VZV + EV Assay Kit

CDX-170

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-170-01-40P3
Basic UDI-DI: B-CDX-170-01-40P3
Reference: CDX-170-01-40
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra HSV 1/2, VZV + EV Assay Kit

CDX-170

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-170-01-20NV
Basic UDI-DI: B-CDX-170-01-20NV
Reference: CDX-170-01-20
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit

CDX-160

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-160-01-20NA
Basic UDI-DI: B-CDX-160-01-20NA
Reference: CDX-160-01-20
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit

CDX-160

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-160-01-100JX
Basic UDI-DI: B-CDX-160-01-100JX
Reference: CDX-160-01-100
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra® SARS-CoV-2 2.0 Assay Kit

CDX-150

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-150-01-20MP
Basic UDI-DI: B-CDX-150-01-20MP
Reference: CDX-150-01-20
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra® SARS-CoV-2 2.0 Assay Kit

CDX-150

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-150-01-100J8
Basic UDI-DI: B-CDX-150-01-100J8
Reference: CDX-150-01-100
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit

CDX-140

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-140Q9
Basic UDI-DI: B-CDX-140Q9
Reference: CDX-140-01-20
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit

CDX-140

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-140-01-40MA
Basic UDI-DI: B-CDX-140-01-40MA
Reference: CDX-140-01-40
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit

CDX-140

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-140-01-100HH
Basic UDI-DI: B-CDX-140-01-100HH
Reference: CDX-140-01-100
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details