Identity
- Trade Name
- ABX Pentra CRP Cal EUDAMEDFDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, calibrator FDA UDI
- Device Name
- ABX Pentra CRP Cal EUDAMED
- Model / Reference
- A11A01616 EUDAMED1220001616 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230004821 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_crp_calMN EUDAMED
- 510(k) Number
- K061138 FDA UDI
- FDA Product Code
- JIS FDA UDI
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- C-reactive protein (CRP) IVD, calibrator FDA UDI
Classification
- Device Class
- Class C 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 CRP Cal 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_crp_calMN | 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 f0b8b8db-37f9-4724-a7a0-60d29f611178 61 fields · synced Jun 18, 2026
- FDA UDI 111b77ee-6183-423a-a2bd-1de2cd9076a6 33 fields · synced May 29, 2026