LEPU Medical SARS-CoV-2 Antigen Rapid Test Kit (Price per pallet incl. 3,000 tests)

This product is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from anterior nasal swabs. Ships from Finland. Price per pallet (20 cartons = 3000 tests) 1,50€ per test +24% VAT for all orders to non-EU countries. This product is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from anterior nasal swabs that are self-collected by an individual aged 18 years or older or are collected by an adult from an individual younger than 18 years old. This test is intended for use in individuals with symptoms or other epidemiological reasons to suspect a COVID-19 infection. This product is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. EN ISO 13485:2016 Medical devices – quality management systems - requirements for regulatory purposes EN ISO 14971:2019 Medical devices – application of risk management to medical devices EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices EN ISO 18113-1:2011 In vitro diagnostic medical devices – information supplied by the manufacturer (labelling) – Part 1: terms, definitions and general requirements EN ISO 18113-2:2011 In vitro diagnostic medical devices – information supplied by the manufacturer (labelling) – Part 2: in vitro diagnostic reagents for professional use EN ISO 23640:2015 In vitro diagnostic medical devices – evaluation of stability of in vitro diagnostic regents EN 13612:2002/AC: 2002 Performance evaluation of in vitro diagnostic medical devices IEC 62366-1:2015 Application of usability engineering to medical devices Packing: Carton content: 150 test kits Carton dimensions: 59 x 32 x 48 cm Carton weight: 10.5 kg