CHORUS MYCOPLASMA PNEUMONIAE IgA

Primary DI

08033891327552

Basic UDI-DI Code

803389132CHORUSMYA00B6

Reference

81033

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

DIESSE Diagnostica Senese S.p.A

"CHORUS Mycoplasma pneumoniae IgA (REF 81033) is an immunoassay kit for the automated semi-quantitative determination of IgA antibodies against Mycoplasma pneumoniae. Mycoplasma Pneumoniae is the most common etiological agent causing pneumonia acquired in community environments. The IgA represent the highest sensitivity marker in case of an infection in progress, a reinfection, or a recent infection; therefore, the kit is used as an aid in the diagnosis of pneumonia 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).