- Joined
- Jan 22, 2007
- Messages
- 9,992
So evidently the test had not been cleared by the FDA?
Not Detected
Final BN
Testing was performed using the cobas(R) SARS-CoV-2 test.
This test was developed and its performance characteristics determined
by LabCorp Laboratories. This test has not been FDA cleared or
approved. This test has been authorized by FDA under an Emergency Use
Authorization (EUA). This test is only authorized for the duration of
time the declaration that circumstances exist justifying the
authorization of the emergency use of in vitro diagnostic tests for
detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection
under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.
Not Detected
Final BN
Testing was performed using the cobas(R) SARS-CoV-2 test.
This test was developed and its performance characteristics determined
by LabCorp Laboratories. This test has not been FDA cleared or
approved. This test has been authorized by FDA under an Emergency Use
Authorization (EUA). This test is only authorized for the duration of
time the declaration that circumstances exist justifying the
authorization of the emergency use of in vitro diagnostic tests for
detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection
under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.