CA19-9 CLIA Microparticles

Primary DI

06970150908348

Basic UDI-DI Code

697015090000010GK

Reference

CMB0802

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Autobio Diagnostics Co., Ltd.

The CA19-9 CLIA Microparticles assay and AutoLumo CA19-9 Calibrators are used together based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of CA19-9 (Carbohydrate Antigen 19-9) in human serum. Clinical determination of CA19-9 is used for dynamic monitoring of patients, which acts as an aid of disease progression or treatment determination of digestive tract malignant tumors such as pancreas.

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).