GastroPanel Four-in-Oneᵀᴹ

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 Four-in-Oneᵀᴹ

UDI-DI code

06419587606088

Basic UDI-DI

B-06419587606088

Reference / catalog number

606080

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 Four-in-One test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17) and IgG antibodies against Helicobacter pylori (Hp) from human EDTA plasma samples. The dedicated software GastroSoft can be used for result interpretation and reporting of all four assays of GastroPanel Four-in-One. Test can be conducted either manually or automatically by the healthcare professionals. GastroPanel Four-in-One 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, the test aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01021499MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification