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| EMDDB code |
21986
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| Basic UDI-DI |
803389132CHORUSEAM0052
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| Seadme klass |
In vitro diagnostikameditsiiniseade
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| Medical Device Nomenclature |
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| Risk class |
Class C
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| Appliance |
-
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| Device name (in Estonian) |
CHORUS EPSTEIN-BARR EARLY ANTIGEN IgM
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| Device name (in English) |
CHORUS EPSTEIN-BARR EARLY ANTIGEN IgM
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| Intended use (is Estonian) |
CHORUS EPSTEIN-BARR VARAJANE ANTIGEEN IgM on
immunoanalüüsi komplekt automatiseeritud kvalitatiivseks
IgM klassi antikehade määramiseks Epstein-Barri varajase antigeeni vastu.
Test viiakse läbi inimese seerumil, kasutades ühekordset seadet, mida kasutatakse CHORUS/CHORUS TRIO/CHORUS EVO instrumentidel. Komplekt on mõeldud Epstein-Barri viiruse nakatumise tuvastamiseks, et aidata seotud diagnoosimisel.
Seda tohivad kasutada ainult professionaalsed laborikasutajad.
Test ei ole mõeldud nakkusohtliku aine tuvastamiseks veres, vere komponentides, rakkudes, kudedes, organites või nende derivaatides, et hinnata nende sobivust vereülekandeks, siirdamiseks või rakkude manustamiseks.
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| Intended use (in English) |
CHORUS EPSTEIN-BARR EARLY ANTIGEN IgM is an
immunoassay kit for the automated qualitative
determination of IgM class antibodies against Epstein Barr Early Antigen.
The test is performed on 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.
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| Type/model/article number |
81059
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| Notified body |
0123
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| Manufacturer |
DIESSE Diagnostica Senese S.p.A
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| In register from |
05/08/2025
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| Entry status |
Active
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| Reimbursed by EHIF |
Tervisekassa soodustus puudub
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