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

CHORUS CARDIOLIPIN-G

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

Basic Information

Primary DI
08033891329273
Basic UDI-DI Code
803389132CHORUSCLPG008Z
Reference
86046/12
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market

Additional Description

"CHORUS Cardiolipin-G (REF 86046 - 86046/12) is an immunoassay kit for the automated semi-quantitative determination of IgG 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"

CND Nomenclature Codes

Code Description
W0102100501 ANTI-CARDIOLIPIN ANTIBODIES

Available In Countries

🇮🇹 Italy

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