Identity
- Trade Name
- ABX Pentra CRP CP EUDAMEDFDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- ABX Pentra CRP CP EUDAMED
- Model / Reference
- A11A01611 EUDAMED1220001611 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230004791 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_crpBF EUDAMED
- 510(k) Number
- K061138 FDA UDI
- FDA Product Code
- DCK FDA UDI
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
- GMDN Term
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5270 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 CRP CP by Horiba Abx Sas — Class C — 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_crpBF | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (2)
- EUDAMED ab9c62a7-5ce8-417e-ad17-59b5a5d8646b 61 fields · synced Jun 19, 2026
- FDA UDI 8a36310d-9820-4db2-8238-0f8f23539a25 33 fields · synced May 30, 2026