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33 device results listed.

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BlueDiver Quantrix Liver 10 IgG

BlueDiver Quantrix Liver

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023682067
Basic UDI-DI: 542502368BDQLIVERQV
Reference: LIVER10Q
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

BlueDiverDot Liver5 IgG

BlueDiverDot Liver

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681497
Basic UDI-DI: 542502368BDDLIVERKL
Reference: LISDIV-24
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Liver5 IgG

BlueDot Liver

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680483
Basic UDI-DI: 542502368BDLIVERBF
Reference: LISD-24
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

QUANTA Flash

QUANTA Flash® LKM-1 Reagents

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950767008
Basic UDI-DI: B-08426950767008
Reference: 701298
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-LKM-1 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769475
Basic UDI-DI: B-06975070769475
Reference: 14000879
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-LKM-1 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761004
Basic UDI-DI: B-06975070761004
Reference: 18119001
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

LKM-1-Ab ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325004238
Basic UDI-DI: B-04049325004238
Reference: RE70911
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:09

Manufacturer products View details

EliA LKM-1 Well

EliA LKM-1

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066020600
Basic UDI-DI: 7333066BUDI0027M2
Reference: 14-6648-01
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

Liver Profile Dot for BDI

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687475
Basic UDI-DI: 542502368BDDLIVERKL
Reference: AD LIVERDBD
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 30.06.2026 22:48

Manufacturer products View details

06950617403753

IM4410468 IM4411468 IM4414468 IM4415468

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403753
Basic UDI-DI: 69506174IM441468EH
Reference: IM4415468
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403746

IM4410468 IM4411468 IM4414468 IM4415468

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403746
Basic UDI-DI: 69506174IM441468EH
Reference: IM4414468
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403739

IM4410468 IM4411468 IM4414468 IM4415468

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403739
Basic UDI-DI: 69506174IM441468EH
Reference: IM4411468
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403722

IM4410468 IM4411468 IM4414468 IM4415468

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403722
Basic UDI-DI: 69506174IM441468EH
Reference: IM4410468
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDot Liver7 IgG

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680599
Basic UDI-DI: 542502368BDLIVERBF
Reference: LI7D-24
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

BlueDot Liver10 IgG

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680650
Basic UDI-DI: 542502368BDLIVERBF
Reference: LI10D-24
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

BlueDot Mitochondria2 IgG + IgM

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680667
Basic UDI-DI: 542502368BDLIVERBF
Reference: MI2D-24
EMDN: W0102100703
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

BlueDiverDot Liver7 IgG

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681503
Basic UDI-DI: 542502368BDDLIVERKL
Reference: LI7DIV-24
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

BlueDiverDot Liver10 IgG

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681596
Basic UDI-DI: 542502368BDDLIVERKL
Reference: LI10DIV-24
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

BlueDiverDot Mitochondria2 IgG + IgM

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681619
Basic UDI-DI: 542502368BDDLIVERKL
Reference: MI2DIV-24
EMDN: W0102100703
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

Liver Profile 7 Ag Dot

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687154
Basic UDI-DI: 542502368BDLIVERBF
Reference: AD LIVER7D
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details