CHORUS HELICOBACTER PYLORI IgA 

Primary DI

08033891322403

Basic UDI-DI Code

803389132CHORUSPYA00C7

Reference

81062

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 IgA (REF 81062) is an immunoassay kit for the automated qualitative determination of IgA antibodies against Helicobacter pylori. Helicobacter pylori infection causes a systemic (IgM, IgG) and local (IgA) immune response; therefore, 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).