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AQUIOS Immuno-Trol Cells
EUDAMEDFDA UDIClass C (EU MDR)
Ref B23535Model AQUIOS Immuno-Trol Cells
Identity
- Trade Name
- AQUIOS Immuno-Trol Cells EUDAMEDFDA UDI
- Generic Name
- Multiple CD cell marker IVD, control FDA UDI
- Device Name
- AQUIOS Immuno-Trol Cells EUDAMEDFDA UDI
- Model / Reference
- AQUIOS Immuno-Trol Cells EUDAMEDB23535 EUDAMEDFDA UDI
- Description
- AQUIOS Immuno-Trol Cells FDA UDI
Identifiers
- Catalog Number
- B23535 FDA UDI
- Primary DI / UDI-DI
- 15099590225759 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902LSIMMUNOTROLZ6 EUDAMED
- FDA Product Code
- OYE FDA UDIJPK 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
- 864.5220 FDA UDI864.8625 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
AQUIOS Immuno-Trol Cells 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 | 150995902LSIMMUNOTROLZ6 | 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 84200bd6-9d8f-41d7-a790-f18db9ba3809 61 fields · synced Oct 6, 2026
- FDA UDI 4e0edf78-1dbf-4fc1-a66e-b2730eb363ea 34 fields · synced May 30, 2026