GastroPanel® Pepsinogen II

Organization name

Biohit Oyj

SRN

FI-MF-000014642

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW132

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Trade name

GastroPanel® Pepsinogen II

UDI-DI code

06419587060200

Basic UDI-DI

B-06419587060200

Reference / catalog number

606020

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01021499MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER

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