Identity
- Trade Name
- Minilysebio 0.4L EUDAMEDMINILYSEBIO (0.4L) FDA UDI
- Generic Name
- Blood cell lysis reagent IVD FDA UDI
- Device Name
- Minilysebio 0.4L EUDAMED
- Model / Reference
- 0906020 EUDAMED1210906020 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230004722 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023minilysebioVG EUDAMED
- Direct Marketing DI
- 03610230004722 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
Minilysebio 0.4L 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 | 361023minilysebioVG | 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 c82edca6-d6ec-437c-b831-42c68710fcb2 61 fields · synced Jul 15, 2026
- FDA UDI 3c0f2598-cb7a-42e1-a265-021af128eb7a 32 fields · synced May 30, 2026