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Aquios Lysing Reagent Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref B23538Model Aquios Lysing Reagent Kit
Identity
- Trade Name
- Aquios Lysing Reagent Kit EUDAMEDAQUIOS FDA UDI
- Generic Name
- White blood cell count IVD, reagent FDA UDI
- Device Name
- Aquios Lysing Reagent Kit EUDAMEDFDA UDI
- Model / Reference
- Aquios Lysing Reagent Kit EUDAMEDB23538 EUDAMEDFDA UDI
- Description
- AQUIOS Lysing Reagent Kit FDA UDI
Identifiers
- Catalog Number
- B23538 FDA UDI
- Primary DI / UDI-DI
- 15099590225803 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902LSLYSEREAGENTAG EUDAMED
- FDA Product Code
- GGK FDA UDIOYE FDA UDI
- EMDN Code
- W0103080699 REAGENTS FOR FLOW CYTOMETRY - OTHER EUDAMED
- GMDN Term
- White blood cell count IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8540 FDA UDI864.5220 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
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
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 Lysing Reagent Kit by Beckman Coulter Ireland Inc. — Class A — 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 | 150995902LSLYSEREAGENTAG | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (2)
- EUDAMED 0e37aca4-64fb-494e-bfa4-1cc1db2ccadb 61 fields · synced Jun 18, 2026
- FDA UDI 9885cb58-49fc-4343-ae0b-b254be258185 35 fields · synced May 30, 2026