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42 device results listed.

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Lyme IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ILY-R402MA
Basic UDI-DI: B-ILY-R402MA
Reference: ILY-R402
EMDN: W0105010602
EMDN description: LYME ANTIBODY TOTAL
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 48594036043990
Basic UDI-DI: B-48594036043990
Reference: OD-399/5ST
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 20:09

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ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 48594036043983
Basic UDI-DI: B-48594036043983
Reference: OD-398/5ST
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 20:09

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MONO-VIDITEST anti-Borrelia sp. IgG + VIsE

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036043009
Basic UDI-DI: B-38594036043009
Reference: KZ-300-12
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

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MONO-VIDITEST anti-Borrelia sp. IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036043016
Basic UDI-DI: B-38594036043016
Reference: KZ-301-12
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

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ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036043989
Basic UDI-DI: B-28594036043989
Reference: ODZ-398
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

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ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036043996
Basic UDI-DI: B-28594036043996
Reference: ODZ-399
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

Manufacturer products View details

MONO-VIDITEST anti-Borrelia sp. IgG + VIsE

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 18594036043005
Basic UDI-DI: B-18594036043005
Reference: K-300-12
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

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MONO-VIDITEST anti-Borrelia sp. IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 18594036043012
Basic UDI-DI: B-18594036043012
Reference: K-301-12
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products View details

Reagena C6 LYME IgM/IgG EIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-114403M5
Basic UDI-DI: B-114403M5
Reference: 114403
EMDN: W0105010602
EMDN description: LYME ANTIBODY TOTAL
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:48

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LyoSens Lyme Disease Detection qPCR Kit

LYO67

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259868
Basic UDI-DI: B-08683548259868
Reference: LYO67
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:21

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ChainFor Lyme Disease Detection qPCR Kit

CFP96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257932
Basic UDI-DI: B-08683548257932
Reference: CFP96
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:17

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ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 08594036043992
Basic UDI-DI: B-08594036043992
Reference: OD-399
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:45

Manufacturer products View details

ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 08594036043985
Basic UDI-DI: B-08594036043985
Reference: OD-398
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:45

Manufacturer products View details

Lyme Borrelia IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911190
Basic UDI-DI: B-06974238911190
Reference: HLYM077T
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

Borrelia Burgdorferi Antibody Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910261
Basic UDI-DI: B-06974238910261
Reference: HLYM004T
EMDN: W0105010602
EMDN description: LYME ANTIBODY TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

AESKUBLOTS® Borrelia-M

AESKUBLOTS® Borrelia

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504577
Basic UDI-DI: B-04250289504577
Reference: 4007
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

AESKUBLOTS® Borrelia-G

AESKUBLOTS® Borrelia

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504560
Basic UDI-DI: B-04250289504560
Reference: 4006
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

MutaPLEX® Borrelia, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003040
Basic UDI-DI: B-04050598003040
Reference: KG1917032
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:42

Manufacturer products View details

MutaPLEX® Borrelia, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002425
Basic UDI-DI: B-04050598002425
Reference: KG1917096
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:41

Manufacturer products View details