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

CHORUS ANTI-CCP

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

Basic Information

Primary DI
08033891329228
Basic UDI-DI Code
803389132CCP005G
Reference
86094/12
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market

Additional Description

CHORUS ANTI-CCP is an immunoassay kit for automated semi-quantitative detection of IgG class antibodies against cyclic citrullinated peptide (anti-CCP). Since the anti-CCP antibodies are highly specific for Rheumatoid Arthritis (RA) and their detection is one of the ACR (American College of Rheumatology) criteria for classification of RA, the kit is used as an aid to the relative 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.

CND Nomenclature Codes

Code Description
W01021112 ANTI-CYCLIC CITRULLINATED PEPTIDE

Available In Countries

🇮🇹 Italy

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