Manual CLungene COVID-19 Antigen Rapid Test (page 4 of 16) (German)

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CLUNGENE ANTIGEN-SCHNELLTEST

MIT LAIENZULASSUNG

•Zugelassen vom Bundesinstitut für Arzneimittel und

Medizinprodukte (BfArM) zur Eigenanwendung

nach11 Abs. 1 Medizinproduktegesetz Deutschland

•Auf der Liste des Bundesinstitut für Arzneimittel und

Medizinprodukte (BfArm) mit Aktenzeichen der

Sonderzulassung: 5640-S-168/21

•Vom Paul-Ehrlich Institut in der „vergleichenden

Evaluierung der Sensitivität von SARS-CoV-2 Antigen-

Schnelltests“ zum derzeitigen Stand der Technik

bewertet

•Inhalt pro Einzelverpackung:

-1 x Einwegtupfer

-1 x Röhrchen

-1 x Extraktionsreagenz

-1 xTestkassette

•Nasenabstrich

•Sensititvät: 97,1%

•Spezifität 99,4%

•Tes t er g e b ni s n ac h ma x . 1 5 -20 Minuten

•Lagerung bei Raumtemperatur

•Bi-linguale Verpackung (deutsch / englisch)

•Deutschsprachige Packungsbeilage mit Anleitung

•Einzelverpackung (VE:1)

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CLungene COVID-19 Antigen Rapid Test Manual

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