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
|