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Gastrin-17 Advanced

Biohit Oyj · Model 601035 · UDI-DI 06419587010359

510(k) clearances

Adverse events

Recalls

Facilities

Description

Gastrin-17 Advanced test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of human gastrin-17 (G-17) from EDTA plasma or serum samples. The test is intended to aid in diagnosing atrophic gastritis (AG) from patients with Helicobacter pylori infection 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 as G-17 is a direct biomarker of antral structure and function, and an indirect biomarker of gastric corpus. Furthermore, Gastrin-17 Advanced test is intended for screening and monitoring the acid output of the stomach. The test can be conducted either manually or automatically and is to be used by healthcare professionals.

Recalls

Date	Firm	Reason
2018-01-02	Siemens Healthcare Diagnostics, Inc.	Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirol
2018-01-02	Siemens Healthcare Diagnostics, Inc.	Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirol

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.