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Terviseamet

Medical device

MSA code 16826
Põhi UDI-DI
Seadme klass In vitro diagnostikameditsiiniseade
Meditsiiniseadmete nomenklatuur
Risk class General IVD 98/79/EÜ
Appliance -
Device name (in Estonian) Uue Koroonaviiruse (SARS-CoV-2) Antigeeni Kiirtestikomplekt (süljest)
Device name (in English) Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva)
Intended use (is Estonian) The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) is an in vitro diagnostic test for the qualitative detection Nucleoprotein and spike glycoprotein of Coronavirus Disease 2019 in human Oropharyngeal saliva, using the rapid immunochromatographic method as an aid in the diagnosis of SARS-Cov-2 infections. The identification is based on the monoclonal antibodies specific for the novel coronavirus antigen.
Intended use (in English) Uue Koroonaviiruse (SARS-CoV-2) Antigeeni Kiirtestikomplekt (süljest) on in vitro diagnostiline test, millega saab kvalitatiivselt tuvastada 2019. aasta koroonaviiruse nukleoproteiini ja
ogavalgu glükoproteiini olemasolu inimese orofarüngeaalses süljes, kasutades kiiret immunokromatograafilist meetodit SARS-CoV-2 infektsioonide diagnoosimiseks. Viirus
tuvastatakse uue koroonaviiruse antigeenidele vastavate spetsiifiliste monoklonaalsete antikehade põhjal.
Type/model/article number K590516D
Additional information 1 test eraldi pakendatuna, 5 testi eraldi pakendatuna, 20 testi eraldi pakendatuna
Manufacturer Hangzhou Realy Tech Co., Ltd.
Authorised representative Luxus Lebenswelt GmbH
In register from 08/11/2021
Status Active
EHK soodustus EHK soodustus puudub
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