Abx Pentra Tpu Cal

FDA UDI

Class II (US FDA UDI)

by Horiba Abx

Identity

Trade Name: ABX PENTRA TPU CAL FDA UDI
Generic Name: Total protein IVD, calibrator FDA UDI
Model / Reference: 1220001898 FDA UDI

Identifiers

Primary DI / UDI-DI: 03610230005590 FDA UDI
510(k) Number: K092570 FDA UDI
FDA Product Code: JIT FDA UDI
GMDN Term: Total protein IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Total protein IVD, calibrator

Abx Pentra Tpu Cal by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total protein IVD, calibrator.

VITROS — Ortho-Clinical Diagnostics · Class II
Dimension Vista® UCFP CAL — Siemens Healthcare Diagnostics · Class II
JAS Diagnostics — Drew Scientific , Ltd. · Class II
Dimension® UCFP Calibrator — Siemens Healthcare Diagnostics · Class II
Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
Atellica CH UCFP Calibrator — Siemens Healthcare Diagnostics · Class II
ADVIA Chemistry UCFP Calibrator — Siemens Healthcare Diagnostics · Class II
VITROS — Ortho-Clinical Diagnostics · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Horiba Abx

Sources (1)

FDA UDI 9ab6d2a6-dc75-4ab9-9e9d-0e6cf59ffacd 33 fields · synced May 30, 2026