*Granted Emergency Use Authorization by the FDA on 5/29/2020*
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.
This Rapid Test Kit is to be read at 10 minutes allowing rapid determination of IgG and/or IgM presence. The COVID-19 Rapid Test Kit is both sensitive and specific for the IgG and IgM antibodies.
***These tests are for Medical professional use only and can only be ran Moderate/high complex lab/office settings. They are Not for home or OTC use!
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Quantity: 25 tests per box
Availability: Subject to availability
Product Code: GCCOV-402A HG
Call us at 419-852-2464 or email email@example.com for pricing! DO NOT PLACE ORDER ONLINE!