Identity
- Trade Name
- ABX Eosinofix 1L EUDAMEDABX EOSINOFIX (1L) FDA UDI
- Generic Name
- Blood cell lysis reagent IVD FDA UDI
- Device Name
- ABX Eosinofix 1L EUDAMED
- Model / Reference
- 0206010 EUDAMED1210206010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230004432 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023eosinofix3H EUDAMED
- Direct Marketing DI
- 03610230004432 EUDAMED
- FDA Product Code
- GGK FDA UDI
- EMDN Code
- W0103010103 COMPLETE CELL COUNT EUDAMED
- GMDN Term
- Blood cell lysis reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8540 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 Eosinofix 1L 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 | 361023eosinofix3H | 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 d0155133-129a-4fa9-b2b0-cb0c5fa119a4 61 fields · synced Jun 19, 2026
- FDA UDI 51442665-11de-4270-92bb-33d8955d092e 32 fields · synced May 30, 2026