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Terviseamet
FOR VISUALLY IMPAIRED

Medical device

MSA code 15791
Basic UDI-DI
Seadme klass In vitro diagnostikameditsiiniseade
Medical Device Nomenclature
Risk class General IVD 98/79/EC
Appliance -
Device name (in Estonian) Koroonaviiruse Ag kiirtest (tampooniga)
Device name (in English) Coronavirus Ag Rapid Test Cassette (Swab)
Intended use (is Estonian) Koronaviiruse Ag kiirtestikassett (ninakaape tampoon) on in vitro immunokromatograafiline test nukleokapsiidvalgu antigeeni kvalitatiivseks tuvastamiseks SARS-CoV-2-st ninaneelu (NP) tampooniproovides otse või pärast seda, kui tampoonid on lisatud üksikisikute viirustransportööridesse. keda tervishoiuteenuse osutaja kahtlustab COVID-19-s. See on ette nähtud SARS-CoV-2 infektsioonide kiireks diagnoosimiseks.
Intended use (in English) The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid rotein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.
Type/model/article number GCCOV-502a
Manufacturer Healgen Scientific Limited Liability Company
Authorised representative Shanghai International Holding Corporation GmbH (Europe)
In register from 11/19/2020
Entry status Active
Reimbursed by EHIF Tervisekassa soodustus puudub
Documents related to medical device model
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