invitro diagnostic test SARS CoV 2 IgM/IgG Rapid Test
invitro diagnostic test for the qualitative determination of COVID-19’s IgM and IgG antibodies
Specification: 40 pieces + insert, buffer and pipette
Certificates / Standard: EN ISO 15223-1:2016 EN 136122002 EN ISO 13485:2016 EN ISO 18113-1:2011 EN ISO 23640:2015 EN 136412002 EN ISO 14971:2012 EN ISO 18113-2:2011 EN ISO 175112003
Tests:
Relative Specificity: 100%
Relative Sensitivity (infection time 4-10 days, IgM & IgG): 81.25%
Relative Sensitivity (infection time 11-24 days, IgM & IgG): 97.1%
Accuracy (infection time 4-10 days, IgM & IgG): 94.6%
Accuracy (infection time 11-24 days, IgM & IgG): 99.3%
Total accuracy: 95.1%
Packaging: box/carton 18/720
MOQ: 10 000 pcs