CHORUS HELICOBACTER PYLORI IgG

Primary DI

08033891322397

Basic UDI-DI Code

803389132CHORUSPYG00D5

Reference

81060

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

DIESSE Diagnostica Senese S.p.A

"CHORUS HELICOBACTER PYLORI IgG (REF 81060) is an immunoassay kit for the automated semi-quantitative determination of IgG antibodies against Helicobacter pylori. Helicobacter pylori infection causes a systemic (IgM, IgG) and local (IgA) immune response. Since IgG levels rise during infection and remain constant over time, the kit is used as an aid in the diagnosis of Helicobacter pylori infection. The test, performed in human serum using a disposable device applied to the CHORUS and CHORUS TRIO instruments, must be used by professional laboratory personnel only. The device is For In Vitro Diagnostic Use Only."

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).