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Terviseamet

Medical device

MSA code 17844
Põhi UDI-DI
Seadme klass In vitro diagnostikameditsiiniseade
Meditsiiniseadmete nomenklatuur
Risk class General IVD 98/79/EÜ
Appliance -
Device name (in Estonian) Chorus Helicobacter pylori IgG
Device name (in English) Chorus Helicobacter pylori IgG
Intended use (is Estonian) Helicobacter Pylori-vastaste IgG-klassi antikehade poolkvantitatiivne määramine inimseerumis kasutades Chorus instrumentidel ühekordseid testseadmeid
Intended use (in English) Semiquantitative determination of IgG-class antibodies to Helicobacter Pylori in human serum, using a disposable device applied on the Chorus instruments
Type/model/article number 81060
Manufacturer Diesse Diagnostica Senese Spa
In register from 06/27/2022
Status Active
EHK soodustus EHK soodustus puudub
Documents related to medical device model
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