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Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies
EUDAMEDClass IVD General (EU MDR)
Ref MB00173Model ANA-15, 16 Tests
Identity
- Trade Name
- Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies EUDAMED
- Device Name
- Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies EUDAMED
- Model / Reference
- ANA-15, 16 Tests EUDAMEDMB00173 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030400934 EUDAMED
- Basic UDI-DI
- B-06924030400934 EUDAMED
- EMDN Code
- W0102100101 ANA 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 Antinuclear Antibodies 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-06924030400934 | 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 ae8c556d-86eb-4366-9960-b8ffe323334e 61 fields · synced Jun 18, 2026