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| EMDDB code |
21984
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| Basic UDI-DI |
803389132CHORUSEBMII00D7
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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 VCA IgM II
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| Device name (in English) |
CHORUS EPSTEIN-BARR VCA IgM II
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| Intended use (is Estonian) |
CHORUS EPSTEIN-BARR VCA IgM II on immuunanalüüsi komplekt, mis on mõeldud IgM klassi antikehade automatiseeritud kvalitatiivseks määramiseks Epstein-Barr viiruse kapsiidi antigeeni (VCA) 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.
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| Intended use (in English) |
CHORUS EPSTEIN BARR VCA IgM II is an immunoassay kit
for the automated qualitative determination of IgM class
antibodies against Epstein-Barr Viral Capsid Antigen
performed 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.
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| Type/model/article number |
81054
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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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