GastroPanel® Pepsinogen II

Primary DI

06419587060200

Basic UDI-DI Code

B-06419587060200

Reference

606020

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Biohit Oyj

GastroPanel Pepsinogen II (PGII) test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of human pepsinogen II from EDTA plasma samples and is intended to be used in conjunction with the other tests of GastroPanel Unified (REF 606400): GastroPanel Pepsinogen I (REF 606010), GastroPanel Gastrin-17 (REF 606035), and GastroPanel Helicobacter pylori (REF 606040). The dedicated software GastroSoft can be used for result interpretation and reporting of all four tests of GastroPanel Unified. Test can be conducted either manually or automatically by the healthcare professionals. GastroPanel Unified test is intended for diagnosing H. pylori infection and atrophic gastritis (AG) from patients with dyspeptic symptoms or at risk to develop malignant cellular changes in stomach mucosa. In addition, GastroPanel Unified test aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa. The level of pepsinogen II (PGII) biomarker reflects the status of entire gastric mucosa. Thus, the PGII test complements the GastroPanel Pepsinogen I (PGI) test (REF 606010) to aid in diagnosis of atrophic corpus gastritis. In addition, the PGII test is used for screening of mucosal inflammation and monitoring the successful eradication of H. pylori.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).