CHORUS ENA-6 S

Primary DI

08033891323134

Basic UDI-DI Code

803389132CHORUSENA6S00BK

Reference

86012

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

DIESSE Diagnostica Senese S.p.A

"CHORUS ENA-6 S is an immunoassay kit for the automated qualitative determination of IgG class antibodies against 6 cellular and nuclear antigens (SS-A, SS-B, Scl-70, Sm, snRNP/Sm and Jo-1). As ENA antibodies are widely used as a serologic marker of systemic autoimmune rheumatic disease, the kit is used as an aid to related diagnosis. The test performed in human serum, using a disposable device applied on the CHORUS and CHORUS TRIO instruments, must be used by professional laboratory users only."

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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