PIVKA-II CLIA Microparticles

Primary DI

06970150905880

Basic UDI-DI Code

697015090000083HE

Reference

CMB2002

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Autobio Diagnostics Co., Ltd.

The PIVKA-II CLIA Microparticles assay and AutoLumo PIVKA-II Calibrators are used together are based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of PIVKA-II (Protein Induced by Vitamin K Absence or Antagonist-II) in human serum. Clinical determination of PIVKA-II is used for dynamic monitoring of patients, which acts as an aid of disease progression or treatment determination of liver cancer.

The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).