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Abx Pentra Lipase Cp
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref A11A01631
by Horiba Abx
Identity
- Trade Name
- ABX PENTRA LIPASE CP EUDAMEDFDA UDI
- Generic Name
- Lipase IVD, kit, spectrophotometry FDA UDI
- Device Name
- ABX Pentra Lipase CP EUDAMED
- Model / Reference
- A11A01631 EUDAMED1220001631 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230004944 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03610230004944 EUDAMED
- FDA Product Code
- CHI FDA UDI
- EMDN Code
- W01010123 LIPASE EUDAMED
- GMDN Term
- Lipase IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1465 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lipase IVD, kit, spectrophotometry
Abx Pentra Lipase Cp by Horiba Abx — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Lipase IVD, kit, spectrophotometry.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
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 273ddb7f-5ab7-4211-9805-03d67f76c755 32 fields · synced Jul 8, 2026
- EUDAMED 37535ff8-da9f-4001-9a05-e03c9e0b7ba0 61 fields · synced Jul 8, 2026