Identity
- Trade Name
- ABX Pentra Uric Acid CP EUDAMEDFDA UDI
- Generic Name
- Uric acid IVD, kit, spectrophotometry FDA UDI
- Device Name
- ABX Pentra Uric Acid CP EUDAMED
- Model / Reference
- A11A01670 EUDAMED1220001670 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005231 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_uric_acidYJ EUDAMED
- 510(k) Number
- K060205 FDA UDI
- FDA Product Code
- KNK FDA UDI
- EMDN Code
- W01010232 URIC ACID EUDAMED
- GMDN Term
- Uric acid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1775 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
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
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 Uric Acid CP 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_uric_acidYJ | 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 df4812d4-478c-4297-bae6-ef2f55a1eb72 61 fields · synced Aug 1, 2026
- FDA UDI 5d60213a-7d28-4e20-891c-3fa91ece9f3e 33 fields · synced May 30, 2026