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

CHORUS ANA-8

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

Basic Information

Primary DI
08033891329112
Basic UDI-DI Code
803389132CHORUSANA8003E
Reference
86010/12
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market

Additional Description

"CHORUS ANA-8 is an immunoassay kit for automated qualitative detection of IgG class antibodies against 8 cellular and nuclear antigens (Sm, U1-snRNP, SS-A, SS-B, snRNP/Sm, Scl-70, Jo-1 and CenpB). As ANA 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 attached to the CHORUS and CHORUS TRIO instruments, must be used by professional laboratory users only."

CND Nomenclature Codes

Code Description
W0102100101 ANA SCREENING

Available In Countries

🇮🇹 Italy

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