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AQUIOS Tetra-2+ Panel
EUDAMEDFDA UDIClass C (EU MDR)
Ref B23534Model AQUIOS Tetra
Identity
- Trade Name
- AQUIOS Tetra-2+ Panel EUDAMEDFDA UDI
- Generic Name
- Multiple CD cell marker IVD, antibody FDA UDI
- Device Name
- AQUIOS Tetra EUDAMEDAQUIOS Tetra-2+ Panel CD45-FITC/(CD56 + CD16)-RD1/CD19-ECD/CD3-PC5 FDA UDI
- Model / Reference
- AQUIOS Tetra EUDAMEDB23534 EUDAMEDFDA UDI
- Description
- AQUIOS Tetra-2+ Panel CD45-FITC/(CD56 + CD16)-RD1/CD19-ECD/CD3-PC5 FDA UDI
Identifiers
- Catalog Number
- B23534 FDA UDI
- Primary DI / UDI-DI
- 15099590225735 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902LSANTIBODYREARD EUDAMED
- FDA Product Code
- OYE FDA UDI
- EMDN Code
- W0103080106 ANTIBODIES FOR LYMPHOCYTE SUBTYPING EUDAMED
- GMDN Term
- Multiple CD cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 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
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
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 Tetra-2+ Panel 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 | 150995902LSANTIBODYREARD | 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 2c614ac9-5123-4cc2-b531-9aa82a456813 61 fields · synced Oct 6, 2026
- FDA UDI 7906ca99-a971-4d13-90a6-debb64cc111d 34 fields · synced May 30, 2026