|
|
| EMDDB code |
21983
|
| Basic UDI-DI |
803389132CHORUSEBN005E
|
| Seadme klass |
In vitro diagnostikameditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
Class C
|
| Appliance |
-
|
| Device name (in Estonian) |
CHORUS EPSTEIN-BARR EBNA IgG
|
| Device name (in English) |
CHORUS EPSTEIN-BARR EBNA IgG
|
| Intended use (is Estonian) |
CHORUS EPSTEIN-BARR EBNA IgG on immuunanalüüsi komplekt, mis on mõeldud IgG klassi antikehade automatiseeritud kvalitatiivseks määramiseks Epstein-Barr tuumaantigeeni (EBNA) vastu inimese seerumis, kasutades ühekordset seadet, mida kasutatakse CHORUS/CHORUS TRIO/CHORUS EVO instrumentidel. Komplekt on ette nähtud Epstein-Barr viiruse nakkusega kokkupuute tuvastamiseks, et aidata kaasa seotud diagnoosimisele.
Seda tohivad kasutada ainult professionaalsed laborikasutajad. Test ei ole mõeldud nakkusohtliku aine kokkupuute tuvastamiseks veres, vere komponentides, rakkudes, kudedes, elundites või nende derivaatides, et hinnata nende sobivust vereülekandeks, siirdamiseks või rakkude manustamiseks.
|
| Intended use (in English) |
CHORUS EPSTEIN-BARR EBNA IgG is an immunoassay kit for the automated qualitative determination of IgG class
antibodies against Epstein Barr Nuclear Antigen (EBNA) in
human serum, using a disposable device applied on the
CHORUS/CHORUS TRIO/CHORUS EVO instruments.
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.
|
| Type/model/article number |
81057
|
| Notified body |
0123
|
| Manufacturer |
DIESSE Diagnostica Senese S.p.A
|
| In register from |
05/08/2025
|
| Entry status |
Active
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
|
|
|
|
|
