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ClearLLab Control Cells Abnormal
EUDAMEDFDA UDIClass C (EU MDR)
Ref B90003Model ClerLLab Control Cells
Identity
- Trade Name
- ClearLLab Control Cells Abnormal EUDAMEDClearLLab 10C FDA UDI
- Generic Name
- Multiple CD cell marker IVD, control FDA UDI
- Device Name
- ClearLLab Control Cells abnormal FDA UDI
- Model / Reference
- ClerLLab Control Cells EUDAMEDB90003 EUDAMEDFDA UDI
- Description
- ClearLLab Control Cells abnormal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590694975 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902CLControlCellsRW EUDAMED
- FDA Product Code
- PWD FDA UDI
- EMDN Code
- W0103080403 LYMPHOCYTE SUBTYPING CONTROLS EUDAMED
- GMDN Term
- Multiple CD cell marker IVD, control 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
Yes
EUDAMED
Animal Tissues
No
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 Control Cells Abnormal 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 | 150995902CLControlCellsRW | 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 34ad344a-50ce-44ab-a484-43e8d11f3039 61 fields · synced Oct 6, 2026
- FDA UDI 38ee3bc5-2736-4d72-8add-5be4dfcf886b 33 fields · synced May 30, 2026