
Siemens Healthineers Spring Forum on COVID-19 Testing
Join our hybrid event!
Online at siemens-healthineers.com/eccmid
In-person at ECCMID 2022, Lisbon, Portugal
Did this information help you?
FTD R&D in silico report on file, March 2022.
The SARS-CoV-2 molecular and antibody tests have not been FDA-cleared or approved. These tests have been authorized by FDA under an EUA for use by authorized laboratories. The molecular test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The antibody test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. These 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. Product availability may vary from country to country and is subject to varying regulatory requirements.
The SARS-CoV-2 Antigen Assay has not been reviewed by the FDA. In the U.S., use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing.
For the CLINITEST Rapid COVID-19 Antigen Self-Test, customers may choose between the various country offerings in order to purchase products, but please note products ordered via a specific country page may only be delivered within that specific geography.