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22 device results listed.

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BioCLIA Autoimmune Control Set, GBM

GBM, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404321
Basic UDI-DI: B-06924030404321
Reference: MY00317
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, GBM

GBM, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415624
Basic UDI-DI: B-06924030415624
Reference: MY00113C
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, GBM

GBM, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403300
Basic UDI-DI: B-06924030403300
Reference: MY00215
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, GBM

GBM, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402792
Basic UDI-DI: B-06924030402792
Reference: MY00164
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

08435287148985

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148985
Basic UDI-DI: B-08435287148985
Reference: 44898
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148787

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148787
Basic UDI-DI: B-08435287148787
Reference: 44878
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148527

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148527
Basic UDI-DI: B-08435287148527
Reference: 44852
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:50

Manufacturer products View details

08435287148510

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148510
Basic UDI-DI: B-08435287148510
Reference: 44851
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:50

Manufacturer products View details

08435287148503

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148503
Basic UDI-DI: B-08435287148503
Reference: 44850
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:50

Manufacturer products View details

08435287147919

ANTI-PR3 ANTIBODIES

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287147919
Basic UDI-DI: B-08435287147919
Reference: 44791
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:50

Manufacturer products View details

08435287111842

AUTOANTIBODIES DUO-ANCA/RL (DUO-ANCA/RL)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287111842
Basic UDI-DI: B-08435287111842
Reference: 44964
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:46

Manufacturer products View details

08435287111835

AUTOANTIBODIES DUO-ANCA/RL (DUO-ANCA/RL)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287111835
Basic UDI-DI: B-08435287111835
Reference: 44963
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:46

Manufacturer products View details

08435287106602

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287106602
Basic UDI-DI: B-08435287106602
Reference: 44911
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08012992555699

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992555699
Basic UDI-DI: B-08012992555699
Reference: 55569
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:46

Manufacturer products View details

08012992555668

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992555668
Basic UDI-DI: B-08012992555668
Reference: 55566
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:46

Manufacturer products View details

08012992500569

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500569
Basic UDI-DI: B-08012992500569
Reference: 50056
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500552

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500552
Basic UDI-DI: B-08012992500552
Reference: 50055
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500545

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500545
Basic UDI-DI: B-08012992500545
Reference: 50054
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500538

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500538
Basic UDI-DI: B-08012992500538
Reference: 50053
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

FIDIS Vasculitis

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001384
Basic UDI-DI: B-03532672001384
Reference: MX 007
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:42

Manufacturer products View details