CA50 CLIA Microparticles

Primary DI

06942359508896

Basic UDI-DI Code

697015090000225HA

Reference

CMB0410

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Autobio Diagnostics Co., Ltd.

The CA50 CLIA Microparticles assay and AutoLumo CA50 Calibrators are used together based on a chemiluminescent microparticle immunoassay (CLIA Microparticles) for the quantitative determination of CA50 (Carbohydrate Antigen 50) in human serum. Clinical determination of CA50 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 2 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).