COVID-19 IgG/IgM Rapid Test Cassette 15’ Componenti del Test Kit Type of Technology: Chromatographic Lateral Flow Immunoassay Antibody Type: IgM/IgG Sample Type: Whole Blood/Serum/Plasma Time to Result: 10-20 minutes. Do not read after 20 minutes. Shelf Life of Test Kit: 12 Months. Test Kit Components: IFU, 1 Foil Pouch (containing Test Cassette), 1 lancet, 1 pipette, 1 buffer solution vial. • Provides fast results in under 15 minutes. • Easy to interpret results with 5 conclusions: Negative, IgG & IgM Positive, IgM Only Positive, IgG Only Positive, Invalid. • Detects both IgM and IgG Antibodies. • As simple as a glucose test. • No advanced training required. • Each kit contains everything required to administer test. • Made in EU and CE Certified IVD Negative IgG and IgM Positive IgG Only Positive Invalid Test Invalid Test Invalid Test Invalid Test IgM Only Positive 1 4 2 5 6 3 SARS-CoV-2 IgM/IgG antibody test kit is intended for the in vitro qualitative detection of SARS-CoV-2 IgM and IgG antibodies from human serum, plasma and whole blood samples. The SARS-CoV-2 IgM/IgG rapid test is based on the immunochromatographic method. The SARS- CoV-2 specific IgM/IgG antibodies are detected by SARS-CoV-2 recombinant antigen and mouse anti human IgM/IgG antibodies. PRODUCT CERTIFIED “CE IVD” – REGISTRATION NUM. 1977342 AXELMED S.R.L. Via della Liberazione, 58 / IT 20098 S. Giuliano Milanese (MI) / Italy Tel: +39 02 9828 2694 / Fax: +39 02 9828 5327 / [email protected] C.F. e P.IVA (VAT#): IT 09541170966 / R.E.A. MI 2097286 / ISO 13485:2016 Certified Company www.myaxelmed.com / Axelmed ® and Paradigma ® are trade marks PRODUZIONE DISPOSITIVI MEDICI MEDICAL DEVICES MANUFACTURING Complete SET to carry out 25 tests independently or with unskilled personnel: • 25 Test Cassettes • 25 blood pipettes • 25 finger lancers • 1 lancer penjet • 1 battle of Diluent for 25 tests