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111 device results listed.

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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 AMA-M2 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769390
Basic UDI-DI: B-06975070769390
Reference: 14000728
EMDN: W0102100702
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-PCA IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070767754
Basic UDI-DI: B-06975070767754
Reference: 18158002
EMDN: W0102100705
EMDN description: PARIETAL CELL ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay IgG4 (CLIA)

100 Tests/kit

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761820
Basic UDI-DI: B-06975070761820
Reference: 18150001
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: -
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay ASMA IgG (CLIA)

Sharay SMA IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761448
Basic UDI-DI: B-06975070761448
Reference: 18129001
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-gp210 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761431
Basic UDI-DI: B-06975070761431
Reference: 18123001
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-sp100 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761424
Basic UDI-DI: B-06975070761424
Reference: 18122001
EMDN: W0102100706
EMDN description: SP 100 ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-SLA/LP IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761417
Basic UDI-DI: B-06975070761417
Reference: 18121001
EMDN: W0102100707
EMDN description: ANTIBODIES TO SOLUBLE LIVERANTIGENES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-LC-1 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761400
Basic UDI-DI: B-06975070761400
Reference: 18120001
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
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

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

Sharay AMA-M2 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070760946
Basic UDI-DI: B-06975070760946
Reference: 18111001
EMDN: W0102100702
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

AESKUBLOTS® Liver Pro

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504546
Basic UDI-DI: B-04250289504546
Reference: 4004
EMDN: W0102100701
EMDN description: HEPATITIS AUTOANTIBODY SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

SLA-Ab ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325008250
Basic UDI-DI: B-04049325008250
Reference: RE70791
EMDN: W0102100707
EMDN description: ANTIBODIES TO SOLUBLE LIVERANTIGENES
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

Mitochondrial (AMA)-M2-Ab ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325004252
Basic UDI-DI: B-04049325004252
Reference: RE70931
EMDN: W0102100702
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:09

Manufacturer products 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

Parietalcell-Ab ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325004214
Basic UDI-DI: B-04049325004214
Reference: RE70891
EMDN: W0102100705
EMDN description: PARIETAL CELL ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:09

Manufacturer products View details

CHORUS AMA-M2

CHORUSAMAM

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891323653
Basic UDI-DI: 803389132CHORUSAMAM2008U
Reference: 86084
EMDN: W0102100702
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:15

Manufacturer products View details

CHORUS MACROARRAY LIVER DISEASES

ALDSC

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322625
Basic UDI-DI: 803389132ALDSC00D3
Reference: 80800
EMDN: W0102100701
EMDN description: HEPATITIS AUTOANTIBODY SCREENING
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:15

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

EliA Parietal Cell Well

EliA Parietal Cell

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066015781
Basic UDI-DI: 7333066BUDI0125M3
Reference: 14-5669-01
EMDN: W0102100705
EMDN description: PARIETAL CELL ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details