Abx Pentra Triglycerides Cp
FDA UDIEUDAMEDClass I (US FDA UDI)
by Horiba Abx
Identity
- Trade Name
- ABX PENTRA TRIGLYCERIDES CP EUDAMEDFDA UDI
- Generic Name
- Triglyceride IVD, kit, spectrophotometry FDA UDI
- Device Name
- ABX Pentra Triglycerides CP EUDAMED
- Model / Reference
- A11A01640 EUDAMED1220001640 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005033 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_triglyR5 EUDAMED
- 510(k) Number
- K060854 FDA UDI
- FDA Product Code
- CDT FDA UDI
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
- GMDN Term
- Triglyceride IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1705 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
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Triglyceride IVD, kit, spectrophotometry
Abx Pentra Triglycerides Cp by Horiba Abx — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Triglyceride IVD, kit, spectrophotometry.
- TRIGLYCERIDES (TRIGS) — Randox Laboratories, Ltd.
- AimStrip Tandem Total Triglycerides Test Strips — GERMAINE LABORATORIES, INC. · Class I
- Triglycerides — Roche Diagnostics Corp. · Class I
- ADVIA® Chemistry TRIG_c Reagent — Siemens Healthcare Diagnostics · Class I
- Dimension Vista® Flex® reagent cartridge TRIG — Siemens Healthcare Diagnostics · Class I
- TRIGLYCERIDES SL — VITALSCIENTIFIC
- Triglycerides/Glycerol Blanked — Roche Diagnostics Corp. · Class I
- Triglyceride LiquiColor® — STANBIO LABORATORY, L.P. · Class I
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Horiba Abx
Sources (2)
- FDA UDI b83fd29c-0ccf-4d51-8b35-89b818d9aeaa 33 fields · synced Jul 9, 2026
- EUDAMED 9544b21e-23cf-4de8-9191-9bfe8b4c016a 61 fields · synced Jul 9, 2026