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BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 Screen
EUDAMEDClass IVD General (EU MDR)
Ref MY00127CModel β2 Glycoprotein 1 Screen, 50 Tests/KitRef MY02216CModel BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 Screen EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 Screen EUDAMEDBioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMED
- Model / Reference
- β2 Glycoprotein 1 Screen, 50 Tests/Kit EUDAMEDMY00127C EUDAMEDBioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMEDMY02216C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030415761 EUDAMED06924030416546 EUDAMED
- Basic UDI-DI
- B-06924030415761 EUDAMED6924030BioCLIAAI3N EUDAMED
- Direct Marketing DI
- 06924030416546 EUDAMED
- EMDN Code
- W0102100503 ANTI-B2-GLYCOPROTEIN I ANTIBODIES EUDAMEDW0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMEDCroatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 Screen by HOB Biotech Group Corp., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06924030415761 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06924030415761 | 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 fc682e13-00c7-42d2-bdf0-1678680d8463 61 fields · synced Jul 17, 2026
- EUDAMED 487e25a2-44ce-468e-9717-147c37406436 61 fields · synced May 18, 2026