Pepsinogen Ⅱ CLIA Microparticles

Primary DI

06942359509145

Basic UDI-DI Code

697015090000230H3

Reference

CMB1610

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Autobio Diagnostics Co., Ltd.

The Pepsinogen II CLIA Microparticles assay and AutoLumo Pepsinogen II Calibrators are used together based on a chemiluminescent microparticle immunoassay (CLIA Microparticles) for the quantitative determination of Pepsinogen II (PG II) in human serum. Clinical determination of PG II 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).