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ANTIGEN-SCHNELLTEST
HOTGEN BIOTECH MIT LAIENZULASSUNG
Zugelassen zur Eigenanwendung nach11 Abs. 1
Medizinproduktegesetz Deutschland
Auf der Liste des Bundesinstitut für Arzneimittel und
Medizinprodukte (BfArm) mit Aktenzeichen der
Sonderzulassung: 5640-S-057/21
Erfüllt die vom Paul-Ehrlich Institut in Abstimmung mit
dem Robert-Koch Institut festgelegten Kriterien
Testprinzip: immunchromatographischer Assay
Anterior-nasaler Abstrich
Geeignet zur Eigenanwendung durch Laien (auch bei
jüngeren Schülerinnen und Schülern)
Hohe Genauigkeit (97,31%)
Hohe Spezifität (99,13%)
Hohe Sensitivität (95,37%)
Testergebnis nach 15 Minuten
Lagerung bei Raumtemperatur
Mindesthaltbarkeitsdatum: 31.1.2022
Deutschsprachige Anleitung beiliegend in Verpackung
Nach Zuschlagserteilung, elektronische Bereitstellung
einer englischsprachigen Anleitung
Verpackungseinheit: 1
4


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