Medical device - MSA

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Medical device

MSA code	17845
Põhi UDI-DI
Seadme klass	In vitro diagnostikameditsiiniseade
Meditsiiniseadmete nomenklatuur
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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