Identity
- Trade Name
- BFTROL EUDAMEDFDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- BFTROL EUDAMEDBF Hematology control FDA UDI
- Model / Reference
- 1300039405 EUDAMEDFDA UDI
- Description
- BF Hematology control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230008584 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023bftrolZF EUDAMED
- FDA Product Code
- JPK FDA UDI
- EMDN Code
- W0103010599 HAEMATOLOGY CONTROLS - OTHER EUDAMED
- GMDN Term
- Full blood count IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
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
Yes
FDA UDI
Bftrol by Horiba Abx Sas — Class B — 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 | 361023bftrolZF | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (2)
- EUDAMED c9cc2c16-8275-41a3-85b5-a7ee203857ca 61 fields · synced Jul 10, 2026
- FDA UDI 89b0b020-77a5-47b4-ae0f-e0544f60b192 33 fields · synced May 30, 2026