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Anti-gp210 IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545860
Basic UDI-DI: 697015090000317HG
Reference: CMQ2503
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-SMA IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720256
Basic UDI-DI: 692591270075HG
Reference: C88046G
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:35

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CHI3L1

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718079
Basic UDI-DI: 692591270263HK
Reference: C86111
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CHI3L1

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912721482
Basic UDI-DI: 692591270263HK
Reference: C86111-S
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-SMA IgG

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912724001
Basic UDI-DI: 692591270075HG
Reference: C88046G-S
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

08435287148275

AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148275
Basic UDI-DI: B-08435287148275
Reference: 44827
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:50

Manufacturer products View details

08435287148268

AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148268
Basic UDI-DI: B-08435287148268
Reference: 44826
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:50

Manufacturer products View details

08435287146486

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287146486
Basic UDI-DI: B-08435287146486
Reference: 44648
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287146394

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287146394
Basic UDI-DI: B-08435287146394
Reference: 44639
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287145588

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287145588
Basic UDI-DI: B-08435287145588
Reference: 44558
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287144703

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144703
Basic UDI-DI: B-08435287144703
Reference: 44570
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08012992500651

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500651
Basic UDI-DI: B-08012992500651
Reference: 50065
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:44

Manufacturer products View details

08012992500620

AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500620
Basic UDI-DI: B-08012992500620
Reference: 50062
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500613

AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500613
Basic UDI-DI: B-08012992500613
Reference: 50061
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500521

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500521
Basic UDI-DI: B-08012992500521
Reference: 50052
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

Sharay ASMA IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769574
Basic UDI-DI: B-06975070769574
Reference: 14000757
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
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-gp210 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769512
Basic UDI-DI: B-06975070769512
Reference: 14000756
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
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-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: 06975070769482
Basic UDI-DI: B-06975070769482
Reference: 14000735
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
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 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