Identity
- Trade Name
- ABX Fluocyte 0.5L EUDAMEDABX FLUOCYTE (0.5L) FDA UDI
- Generic Name
- Differentiation solution IVD FDA UDI
- Device Name
- ABX Fluocyte 0.5L EUDAMED
- Model / Reference
- 0904011 EUDAMED1210904011 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230004647 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023fluocyte98 EUDAMED
- Direct Marketing DI
- 03610230004647 EUDAMED
- FDA Product Code
- LED FDA UDI
- EMDN Code
- W0103010102 SPECIFIC RETICULOCYTE REAGENTS EUDAMED
- GMDN Term
- Differentiation solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Market of Registration
- France 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ABX Fluocyte 0.5L by Horiba Abx Sas — 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 | 361023fluocyte98 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (2)
- EUDAMED 9bddc85b-b700-40a9-a241-3751779342f6 61 fields · synced Jun 20, 2026
- FDA UDI 2ddfc074-f1a8-4c18-abb3-67d74f272f57 32 fields · synced May 30, 2026