CHORUS CARDIOLIPIN-M

Primary DI

08033891329280

Basic UDI-DI Code

803389132CHORUSCLPM009X

Reference

86048/12

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

DIESSE Diagnostica Senese S.p.A

"CHORUS Cardiolipin-M (REF 86048 - 86048/12) is an immunoassay kit for the automated semi-quantitative determination of IgM antibodies against Cardiolipin, an acid phospholipid derived from glycerol. Since the detection of antibodies against Cardiolipin IgG and/or IgM is one of the Sydney criteria to define antiphospholipid syndrome (APS), the kit is used as an aid to the related diagnosis. The test, performed in human serum using a disposable device applied to the CHORUS/CHORUS TRIO/CHORUS EVO instruments, must be used by professional laboratory personnel 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).