Pepsinogen Ⅰ CLIA Microparticles

Primary DI

06942359509091

Basic UDI-DI Code

697015090000229HJ

Reference

CMB1510

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Autobio Diagnostics Co., Ltd.

The Pepsinogen I CLIA Microparticles assay and AutoLumo Pepsinogen I Calibrators are used together based on a chemiluminescent microparticle immunoassay (CLIA Microparticles) for the quantitative determination of Pepsinogen I (PG I) in human serum. Clinical determination of PG I is used for monitoring of gastric mucosal function changes. The joint detection of PG I and PG II can be used to monitor the severity of gastric mucosal atrophy, and works as an aid of gastric cancer diagnosis.

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).