Product Description: invitro diagnostic test for the qualitative determination of COVID-19’s IgM and IgG antibodies
Test principal: Colloidal gold
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
Production Lead Time - 2 weeks
Payment Term - 100 % deposit before goods delivery