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Line Immuno Assay (LIA) for the Detection of Antibodies in Autoimmune Vasculitis
EUDAMEDClass IVD General (EU MDR)
Ref MB00178Model Vasculitis-2, 16 TestsRef MB00177Model Vasculitis-3, 16 Tests
Identity
- Trade Name
- Line Immuno Assay (LIA) for the Detection of Antibodies in Autoimmune Vasculitis EUDAMED
- Device Name
- Line Immuno Assay (LIA) for the Detection of Antibodies in Autoimmune Vasculitis EUDAMED
- Model / Reference
- Vasculitis-2, 16 Tests EUDAMEDMB00178 EUDAMEDVasculitis-3, 16 Tests EUDAMEDMB00177 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030400989 EUDAMED06924030400972 EUDAMED
- Basic UDI-DI
- B-06924030400989 EUDAMEDB-06924030400972 EUDAMED
- EMDN Code
- W0102100401 ANCA SCREENING EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Line Immuno Assay (LIA) for the Detection of Antibodies in Autoimmune Vasculitis by HOB Biotech Group Corp., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06924030400989 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- HOB Biotech Group Corp., Ltd.
- EUDAMED SRN
- CN-MF-000023974
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED edc3e61f-071c-4ade-b6e3-b4857e1e0435 61 fields · synced Oct 6, 2026
- EUDAMED c211b2a8-5f6f-4570-b6e0-8a0fc4efef3c 61 fields · synced May 18, 2026