Eu Ivdr Eu Ivd Class C On The Market ๐Ÿ‡ฎ๐Ÿ‡น Italy

CHORUS EPSTEIN-BARR EARLY ANTIGEN IgG

DIESSE Diagnostica Senese S.p.A ยท ๐Ÿ‡ฎ๐Ÿ‡น Italy
Devices (same UDI-DI)
2
Certificates
0
Countries
1
Notified Bodies
0

Basic Information

Primary DI
08033891328986
Basic UDI-DI Code
803389132CHORUSEAG0044
Reference
81058/12
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class C
Status
On The Market

Additional Description

CHORUS EPSTEIN-BARR EARLY ANTIGEN IgG (REF. 81058 - 81058/12) is an Immunoassay kit for the qualitative determination of IgG class antibodies against Epstein Barr Early Antigen in human serum, using a disposable device applied on the CHORUS/CHORUS TRIO/CHORUS EVOinstruments. The kit is intended to detect the exposure to Epstein Barr Virus infection as an aid to the related diagnosis. It must be used by professional laboratory users only. The test is not intended to detect the exposure of the transmissible agent in blood, blood components, cells, tissues, organs or any derivative thereof for the purpose of assessing its suitability for transfusion, transplantation or cell administration.

CND Nomenclature Codes

Code Description
W010504040108 EBV EA IGG

Available In Countries

๐Ÿ‡ฎ๐Ÿ‡น Italy

Related Devices

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Similar Devices

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).

View all