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ClearLLab Bcell tube
EUDAMEDFDA UDIClass C (EU MDR)
Ref B96805Model ClearLLab Panels
Identity
- Trade Name
- ClearLLab Bcell tube EUDAMEDClearLLab 10C FDA UDI
- Generic Name
- Multiple CD cell marker IVD, antibody FDA UDI
- Device Name
- ClearLLab Panels EUDAMEDClearLLab 10C B Cell Tube FDA UDI
- Model / Reference
- ClearLLab Panels EUDAMEDB96805 EUDAMEDFDA UDI
- Description
- ClearLLab 10C B Cell Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590701475 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902CLEARLLABBP EUDAMED
- FDA Product Code
- PWD FDA UDI
- EMDN Code
- W0103080101 ANTIBODIES FOR B AND T-CELL SUBTYPING EUDAMED
- GMDN Term
- Multiple CD cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7010 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
ClearLLab Bcell tube by Beckman Coulter Ireland Inc. — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995902CLEARLLABBP | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (2)
- EUDAMED 8e239bde-5c71-40d5-b2c2-9236ce123ef9 61 fields · synced Oct 6, 2026
- FDA UDI b9ae8478-8b90-4b85-9cdd-7159cb669c78 33 fields · synced May 29, 2026