PCL COVID 19 Ag Gold is an in vitro diagnostic medical device based on the Immunochromatographic assay (ICA) principle for the qualitative detection of SARS-CoV-2 antigens in human saliva, nasal or nasopharyngeal specimens. This test is used to detect antigens of the SARS-CoV-2 virus in people suspected of COVID 19.
Sensitivity: 91.67%
Specificity: 100%
Each box includes:
Filter cap 50 pcs
Extraction Buffer Tube 50 pcs
Applicator for saliva collection 50 pcs
Swab for nasopharyngeal specimen 50 pcs
Test Card 50pcs
Officially approved by Korea Ministry of Food and Drug Safety
Included in European Commission COVID-19 In Vitro Diagnostic Devices and Test Methods Database
Included in Germany Federal Institute for Drugs and Medical Devices – List of Antigen Test for SARS-CoV-2
Included in Ministry of Health of Italy – Medical Device list
Included in Hong Kong Consumer Council Approved Rapid Antigen Test (RAT) Kit
Standard: EN ISO 13485: 2016, EN 13612:2002, EN ISO 13641:2002, EN ISO 14971:2012. EN ISO 15223-1:2016, EN ISO 17511:2003, EN ISO 18113-1:2011, EN ISO 18113-2:2011, EN ISO 23640:2015
Hong Kong Consumer Council Approved Rapid Antigen Test (RT) Kits Search Tool: https://www.consumer.org.hk/en/rapid_antigen_test_search
Expiration Date (Best before use) : 13/01/2024
