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48 device results listed.

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AESKULISA® Borrelia-M

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289501705
Basic UDI-DI: B-04250289501705
Reference: 3803
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

Manufacturer products View details

AESKULISA® Borrelia-G

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289501699
Basic UDI-DI: B-04250289501699
Reference: 3802
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

Manufacturer products View details

ChainFor™

CFP96

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257932
Basic UDI-DI: 868511580PCR67JS
Reference: CFP67P100
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 07:30

Manufacturer products View details

D0003-DNA-Positive Control for Borrrelia burgdorferi

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430881
Basic UDI-DI: B-04262420430881
Reference: D0003
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:45

Manufacturer products View details

K740-Detection of Borrelia burgdorferi

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430430
Basic UDI-DI: B-04262420430430
Reference: K740
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

Manufacturer products View details

EUROMicroblot Anti-Borrelia (IgG)

KN 2131 G

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016148845
Basic UDI-DI: B-04049016148845
Reference: KN 2131-9601 G
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 04:49

Manufacturer products View details

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: 06936983140867
Basic UDI-DI: B-06936983140867
Reference: ILY-402
EMDN: W0105010699
EMDN description: LYME BORRELIOSIS REAGENTS - OTHER
First on market country: Lithuania
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

BORRELIA VIRCLIA® IgG MONOTEST

VCM009

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326664
Basic UDI-DI: 843604032VCM00901CJ
Reference: VCM009
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

BORRELIA VIRCLIA® IgM MONOTEST

VCM010

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326671
Basic UDI-DI: 843604032VCM01001BC
Reference: VCM010
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

IDEIA LYME NEUROBORRELIOSIS KIT

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

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384501854
Basic UDI-DI: 5032384IdeiaLymeUV
Reference: K602811-2
EMDN: W0105010699
EMDN description: LYME BORRELIOSIS REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® Lyme IgM

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026265083
Basic UDI-DI: 357302BUDI000084TA
Reference: 30319
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

Manufacturer products View details

LIAISON® Borrelia IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771101097
Basic UDI-DI: 80567713108804W
Reference: 310880
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:39

Manufacturer products View details

LIAISON® Borrelia IgM Quant

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100038
Basic UDI-DI: 805677131002034
Reference: 310020
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:39

Manufacturer products View details

LIAISON® Borrelia IgM II

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100007
Basic UDI-DI: 80567713100102Z
Reference: 310010
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:39

Manufacturer products View details

VIDAS® Lyme IgG

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026265076
Basic UDI-DI: 357302BUDI000085TC
Reference: 30320
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:50

Manufacturer products View details

Lyme Ab Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840312164
Basic UDI-DI: B-69743840312164
Reference: 3025401
EMDN: W0105010602
EMDN description: LYME ANTIBODY TOTAL
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

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: 58594036043997
Basic UDI-DI: B-58594036043997
Reference: ODZ-399/5ST
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 17.07.2026 02:50

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: 58594036043980
Basic UDI-DI: B-58594036043980
Reference: ODZ-398/5ST
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 17.07.2026 02:50

Manufacturer products View details

+ENTIBORG00400Z

NovaLisa® Borrelia burgdorferi IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIBORG00400Z
Basic UDI-DI: B-+ENTIBORG00400Z
Reference: BORG0040
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details

+ENTIBORM00400+

NovaLisa® Borrelia burgdorferi IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIBORM00400+
Basic UDI-DI: B-+ENTIBORM00400+
Reference: BORM0040
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details