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BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 IgM
EUDAMEDClass B (EU MDR)
Ref MY02215CModel BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control SetRef MY00177Model β2 Glycoprotein 1 IgM, 100 Tests/KitRef MY00126CModel β2 Glycoprotein 1 IgM, 50 Tests/Kit
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 IgM EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMEDBioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 IgM EUDAMED
- Model / Reference
- BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMEDMY02215C EUDAMEDβ2 Glycoprotein 1 IgM, 100 Tests/Kit EUDAMEDMY00177 EUDAMEDβ2 Glycoprotein 1 IgM, 50 Tests/Kit EUDAMEDMY00126C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030416522 EUDAMED06924030402921 EUDAMED06924030415754 EUDAMED
- Basic UDI-DI
- 6924030BioCLIAAI3N EUDAMEDB-06924030402921 EUDAMEDB-06924030415754 EUDAMED
- Direct Marketing DI
- 06924030416522 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMEDW0102100503 ANTI-B2-GLYCOPROTEIN I ANTIBODIES EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Croatia EUDAMEDGermany 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
New Device
No
EUDAMED
BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 IgM by HOB Biotech Group Corp., Ltd. — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6924030BioCLIAAI3N | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 6924030BioCLIAAI3N | Class B | 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 (3)
- EUDAMED 6491e726-80c1-4d08-8c61-8957b7469ab7 61 fields · synced Jul 17, 2026
- EUDAMED 959fc84e-1061-4203-95b0-578656baa083 61 fields · synced May 17, 2026
- EUDAMED b9865dcf-8311-4a3b-84bc-4dfaa8c69236 61 fields · synced May 18, 2026