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.
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.
*The FDA has only granted this test emergency use authorization in a CLIA high-complexity setting. Please refer to your local regulations. To learn more, download the FDA Fact Sheet: Antibody Test Oversight and Use For COVID-1
1 buffer bottle for every 25 tests (4ml total)
25 COVID-19 Cassette Tests (single use IgM/IgG tests)
25 droppers (pipettes)
SYNTRON Bioresearch, Inc was founded in 1986 and manufactures rapid in vitro diagnostic tests and detection readers. SYNTRON is licensed as a Medical Device Establishment by the US FDA and the State of California Department of Health Services. View Establishment Registration. SYNTRON manufactures 101 tests under FDA registration View All Device Listings and are registered to produce QuikPac II Covid-19 IgG & IgM Test. View QuikPac II Device Listing.
QuikPac is FDA Listed and Selling under Notification Pathway. Notification has been provided to the FDA, pending EUA Authorization. COVID-19 Rapid Blood Tests for use by laboratories and healthcare workers at the point-of-care, have not been approved by the FDA. The FDA does not intend to object to the development and distribution of serology tests by commercial manufacturers or laboratories that identify antibodies to SARS-CoV-2 where (1) the test has been validated, (2) notification has been provided to the FDA, and (3) the following information is included in the test report: These test have not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic test should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. This policy is limited to such testing in laboratories or healthcare workers at the point-of-care.
Contact us for specific pricing information. Bulk discounts are available.