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Approved Subject: Beijing Wantai Biopharmaceus Co., Ltd. Product Name: New Coronavirus (2019-nCoV) Antigen Test Kit (Collate Gold Method) (English name WANTAI SARS-CoV-2 Ag Rapid Test) (Colloidal Gold)) Intended Use: New Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal Gold Method) (ENGLISH name WANTAI SARS-CoV-2 Ag Rapid Test) Coloidal Gold) for qualitative testing of new coronavirus (SARS-CoV-2) nuclear crust protein antigens in population pharynx/nasopharyngeal swab specimens Use range: EU countries and ACC-certified countries Duration of use: currently unlimited New coronavirus (2019-nCoV) antigen test kit (collosus gold method) for qualitative detection of new coronaviruses (SARS-CoV-2) in population pharynx/nasopharyngeal swab specimens Nuclear crust protein antigen.
product has not been certified by other countries and international organizations prior to its use.
can be sold in EU countries and countries accredited with EU CE certification after obtaining EU CE certification this time.
can meet clinical use needs, stable performance, sensitivity and specificity.
source: Vantai Bio-Enterprise Announcement