Abx Pentra Hdl Direct Cp
FDA UDIEUDAMEDClass I (US FDA UDI)
by Horiba Abx
Identity
- Trade Name
- ABX PENTRA HDL DIRECT CP EUDAMEDFDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- ABX Pentra HDL Direct CP EUDAMED
- Model / Reference
- A11A01636 EUDAMED1220001636 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230004999 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_hdl_directN8 EUDAMED
- 510(k) Number
- K060854 FDA UDI
- FDA Product Code
- LBR FDA UDI
- EMDN Code
- W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL EUDAMED
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1475 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
No
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: High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
Abx Pentra Hdl Direct Cp by Horiba Abx — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry.
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- Dimension Vista® Flex® reagent cartridge HDLC — Siemens Healthcare Diagnostics · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® HDLD RGT. KIT AU-616 — Carolina Liquid Chemistries Corp. · 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 |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (2)
- FDA UDI 97bc31cb-2d3c-4e8e-838e-f2a4c78c28b7 33 fields · synced Jul 17, 2026
- EUDAMED 8d81c971-3ed2-467b-b4f2-501e11ef4188 61 fields · synced Jul 17, 2026