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Terviseamet

Medical device

MSA code 16964
UDI code
Seadme klass In vitro diagnostikaseade (IVD meditsiiniseade)
Risk class IVD
Appliance -
Device name (in Estonian) SARS-CoV-2 antigeeni kiirtesti komplekt (nina eesosa-või süljeproovist)
Device name (in English) SARS-CoV-2 Antigen Rapid Test Kit (Lower Nasal Swab/Saliva)
Intended use (is Estonian) SARS-CoV-2 antigeeni kiirtesti komplekt on lateraalse vooluga kromatograafiline immuunanalüüs SARS-CoV-2 nukleokapsiidi valkude antigeeni kvalitatiivseks määramiseks inimese nina eesosa või süljeproovist. Toode on mõeldud ainult professionaalseks kasutamiseks in vitro diagnostikas.
Intended use (in English) SARS-CoV-2 antigen rapid test kit is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in lower nasal swab or saliva specimens.
For professional in vitro diagnostic use only.
Type/model/article number SAGP0001 (N1), SAGP0002 (N2), SAGP0005 (N5), SAGP0012 (N12), SAGP0025 (N25)
Manufacturer Selfdiagnostics Deutschland GmbH
In register from 10/13/2021
Status Removed from sale
Date of elimination 11/05/2021
Reason of removal Ootame selgitust tootjalt.
EHK soodustus EHK soodustus puudub
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