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Line Immuno Assay (LIA) for the Detection of Autoantibodies in Autoimmune Liver…
EUDAMEDClass IVD General (EU MDR)
Ref MB00179Model Liver-8, 16 Tests
Identity
- Trade Name
- Line Immuno Assay (LIA) for the Detection of Autoantibodies in Autoimmune Liver Diseases EUDAMED
- Device Name
- Line Immuno Assay (LIA) for the Detection of Autoantibodies in Autoimmune Liver Diseases EUDAMED
- Model / Reference
- Liver-8, 16 Tests EUDAMEDMB00179 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030400996 EUDAMED
- Basic UDI-DI
- B-06924030400996 EUDAMED
- EMDN Code
- W0102100701 HEPATITIS AUTOANTIBODY 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 Autoantibodies in Autoimmune Liver… 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-06924030400996 | 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 (1)
- EUDAMED c29afa71-9092-4494-ab99-1412a3f479a2 61 fields · synced Oct 6, 2026