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BioCLIA Autoimmune Control Set, Cardiolipin Screen
EUDAMEDClass IVD General (EU MDR)
Ref MY00327Model Cardiolipin Screen, 2 x 1mLRef MY00123CModel Cardiolipin Screen, 50 Tests/KitRef BioCLIA Autoimmune Reagent Kit, Cardiolipin ScreenModel BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control SetRef MY00174Model Cardiolipin Screen, 100 Tests/Kit
Identity
- Trade Name
- BioCLIA Autoimmune Control Set, Cardiolipin Screen EUDAMEDBioCLIA Autoimmune Reagent Kit, Cardiolipin Screen EUDAMED
- Device Name
- BioCLIA Autoimmune Control Set, Cardiolipin Screen EUDAMEDBioCLIA Autoimmune Reagent Kit, Cardiolipin Screen EUDAMEDBioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMED
- Model / Reference
- Cardiolipin Screen, 2 x 1mL EUDAMEDMY00327 EUDAMEDCardiolipin Screen, 50 Tests/Kit EUDAMEDMY00123C EUDAMEDBioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMEDBioCLIA Autoimmune Reagent Kit, Cardiolipin Screen EUDAMEDCardiolipin Screen, 100 Tests/Kit EUDAMEDMY00174 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030404420 EUDAMED06924030415723 EUDAMED06924030416461 EUDAMED06924030402891 EUDAMED
- Basic UDI-DI
- B-06924030404420 EUDAMEDB-06924030415723 EUDAMED6924030BioCLIAAI3N EUDAMEDB-06924030402891 EUDAMED
- Direct Marketing DI
- 06924030416461 EUDAMED
- EMDN Code
- W0102100501 ANTI-CARDIOLIPIN 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 Control Set, Cardiolipin 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-06924030404420 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06924030404420 | 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 (5)
- EUDAMED ca835e1d-bbe4-4ec7-8fa3-2ac245bf446a 61 fields · synced Jul 28, 2026
- EUDAMED a3d468e6-e878-46ff-8fc3-1707d39a4cb6 61 fields · synced May 18, 2026
- EUDAMED 11c8816e-c2f6-4b9a-91cd-da0e9e38ddba 61 fields · synced May 18, 2026
- EUDAMED e1240b47-c78e-4c3a-8245-c4f437ea1266 61 fields · synced May 18, 2026
- EUDAMED 11c8816e-c2f6-4b9a-91cd-da0e9e38ddba-1 61 fields · synced Jun 10, 2026