Abx Pentra Urinary Proteins Cp
FDA UDIEUDAMEDClass I (US FDA UDI)
by Horiba Abx
Identity
- Trade Name
- ABX PENTRA URINARY PROTEINS CP EUDAMEDFDA UDI
- Generic Name
- Total protein IVD, kit, spectrophotometry FDA UDI
- Device Name
- ABX Pentra Urinary Proteins CP EUDAMED
- Model / Reference
- A11A01642 EUDAMED1220001642 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005057 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03610230005057 EUDAMED
- FDA Product Code
- JIQ FDA UDI
- EMDN Code
- W01010230 TOTAL PROTEIN EUDAMED
- GMDN Term
- Total protein IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1645 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Total protein IVD, kit, spectrophotometry
Abx Pentra Urinary Proteins Cp by Horiba Abx — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (2)
- FDA UDI ec7e1eb7-0a53-4657-9302-015b0b8bfffc 32 fields · synced Jul 8, 2026
- EUDAMED 4f18422a-39a2-47d9-9cdd-48b9435ab1a3 61 fields · synced Jul 8, 2026