Identity
- Trade Name
- ABX Pentra Phosphorus CP EUDAMEDFDA UDI
- Generic Name
- Inorganic phosphate (PO43-) IVD, kit, spectrophotometry FDA UDI
- Device Name
- ABX Pentra Phosphorus CP EUDAMED
- Model / Reference
- A11A01665 EUDAMED1220001665 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005194 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_phosphorusKU EUDAMED
- 510(k) Number
- K070249 FDA UDI
- FDA Product Code
- CEO FDA UDI
- EMDN Code
- W01010307 PHOSPHATE INORGANIC / PHOSPHORUS EUDAMED
- GMDN Term
- Inorganic phosphate (PO43-) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1580 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Inorganic phosphate (PO43-) IVD, reagent
ABX Pentra Phosphorus CP by Horiba Abx Sas — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Inorganic phosphate (PO43-) IVD, reagent.
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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_phosphorusKU | 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 a53a1cd8-3f54-4af8-ace4-f601c850be8f 61 fields · synced Jun 8, 2026
- FDA UDI 7b5bbbd3-2ff6-4919-8947-8de9051e2bb0 33 fields · synced May 30, 2026