Insurance Billing Phone: 310-905-6441
Insurance Billing FAX: 213-559-0676
Insurance Billing Email: billing@quickmeddx.com
Insurance Billing Phone: 332-208-8824
Insurance Billing FAX: 332-262-5789
Insurance Billing Email: billing@atlantic-laboratory.com
Insurance Billing Phone: 571-534-3973
Insurance Billing FAX: 571-470-8259
Insurance Billing Email: billing@quickmeddx.com
The antibody tests, molecular tests, and antigen tests (together “All tests”) have not been FDA cleared or approved; All tests have been authorized by FDA under EUAs for use by authorized laboratories; The antibody tests have been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; The COVID-19 molecular tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; The COVID-19 and flu panel test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, and influenza B virus, and not for any other viruses or pathogens; and COVID-19, flu, and RSV panel test
has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), and not for any other viruses or pathogens; The antigen tests have been authorized only for the detection of proteins from SARS-CoV-2, and not for any other viruses or pathogens; andAll tests are 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.
This test has been authorized by the FDA under an Emergency Use Authorization (EUA). This means that while Quickmed Diagnostics has validated the test and has the data to believe the test and the collection kit are accurate, 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 detection of 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. Additional studies need to be conducted for this test and others like it to be FDA cleared or approved.
