Eu Ivdr Eu Ivd Class B On The Market 🇮🇹 Italy

CHORUS dsDNA-M

Devices (same UDI-DI)
2
Certificates
0
Countries
1
Notified Bodies
0

Basic Information

Primary DI
08033891327408
Basic UDI-DI Code
803389132CHORUSDSDNAM00V6
Reference
86034
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market

Additional Description

"CHORUS dsDNA-M (REF 86034 - 86034/12) is an immunoassay kit for automated semiquantitative determination of IgM class antibodies against dsDNA. As dsDNA antibodies are widely used as a serologic marker of systemic lupus erythematosus (SLE), the kit is used as an aid to related diagnosis and clinical monitoring. The test, performed in human serum using a disposable device applied to the CHORUS and CHORUS TRIO instruments, must be used by professional laboratory users only."

CND Nomenclature Codes

Code Description
W0102100105 DS DNA - ANTIBODIES

Available In Countries

🇮🇹 Italy

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