Identity
- Trade Name
- ABX Pentra LDL Cal EUDAMEDFDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, calibrator FDA UDI
- Device Name
- ABX Pentra LDL Cal EUDAMED
- Model / Reference
- A11A01678 EUDAMED1220001678 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005255 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_ldl_calKD EUDAMED
- 510(k) Number
- K060854 FDA UDI
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
- GMDN Term
- Low density lipoprotein (LDL) cholesterol IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ABX Pentra LDL Cal 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 | 361023pentra_ldl_calKD | 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 a7163d1b-90b9-4611-bc47-fe33876f95f3 61 fields · synced Jun 20, 2026
- FDA UDI 94c37e18-9d7a-4ff0-a8eb-c8a4ad498943 33 fields · synced May 30, 2026