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BioCLIA Autoimmune Reagent Kit, GAD
EUDAMEDClass IVD General (EU MDR)
Ref MY00193Model GAD, 100 Tests/KitRef MY00142CModel GAD, 50 Tests/Kit
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit, GAD EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit, GAD EUDAMED
- Model / Reference
- GAD, 100 Tests/Kit EUDAMEDMY00193 EUDAMEDGAD, 50 Tests/Kit EUDAMEDMY00142C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030403089 EUDAMED06924030415877 EUDAMED
- Basic UDI-DI
- B-06924030403089 EUDAMEDB-06924030415877 EUDAMED
- EMDN Code
- W0102060105 GAD II ANTIBODIES AND OTHER ICA EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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
BioCLIA Autoimmune Reagent Kit, GAD by HOB Biotech Group Corp., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06924030403089 | 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 01c00a6f-4f49-4587-93e2-7420be273abd 61 fields · synced Jul 18, 2026
- EUDAMED febde5fb-b097-4b2d-903c-1a7bfb3e0a89 61 fields · synced May 19, 2026