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Terviseamet

Medical device

MSA code 17845
Basic UDI-DI
Seadme klass In vitro diagnostikameditsiiniseade
Medical Device Nomenclature
Risk class General IVD 98/79/EÜ
Appliance -
Device name (in Estonian) CHORUS SARS-CoV-2 IgG
Device name (in English) CHORUS SARS-CoV-2 IgG
Intended use (is Estonian) Immuunoensümaatiline meetod semi-kvantitatiivseks SARS-CoV-2 viiruse- vastaste IgG-klassi antikehade määramiseks ninaneelu proovist, kasutades ühekordset monotest seadet Chorus Trio instrumendil.
Intended use (in English) Immunoenzymatic method for the qualitative determination of IgG class antibodies to SARS-CoV-2 virus in human serum, using a disposable device applied on the Chorus and Chorus TRIO instruments.
Type/model/article number 81400
Manufacturer Diesse Diagnostica Senese Spa
In register from 06/27/2022
Status Active
EHK soodustus EHK soodustus puudub
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