FDA & Health Canada Emergency Use Authorized
From Senior Experts In The In-Vitro Diagnostic Field
FDA & Health Canada Approved Serological Technology
This COVID-19 IgG/IgM Rapid Antibody Test device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. This test intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. It is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. An antibody test may not be able to show if you have a current infection, because it can take 1-3 weeks after infection to make antibodies.
The test is approved for laboratory testing and is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC).
With a waiver the test is approved for over-the-counter home self testing in Canada.
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Rapid Test Details
Fast Working: Intuitive Visual Results in 15 Minutes
High Sensitivity: Sensitivity Igg = 100% / Sensitivity Igm = 89.3%
Region: USA & Canada
Type: Rapid Antibody Finger Prick
Manufacturer: Assure Tech
Authorized Settings: CLIA Labs, Point Of Care with CLIA Waiver
Pricing Varies w/ Quantity and Current Market Conditions
Contact Us For Quotes of 500,000 Quantity & Over
Boxes per case: 32
Tests per case: 640
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