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Testing procedures - Import export

AustriaManufacturer/producer

Austria

The CLUNGENE® COVID-19 Antigen Rapid Test Cassette (Nasal Swab) manufactured by Hangzhou Clongene Biotech Co., Ltd. is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasal swab from individuals who are suspected of COVID-19 by their healthcare provider. The COVID-19 Antigen Rapid Test is a lateral flow immunoassay based on the principle of the double­antibody sandwich technique. lf the specimen contains SARS-CoV-2 antigen, a colored test line (T) would be visible in the result window. Absence of the T line suggests a negative result. The control line (C) is used for procedural control, and should always appear if the test procedure is performed properly.

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Testing procedures - Import export

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