
Siemens Healthineers at ESCV 2022
We pioneer breakthroughs in healthcare.
For everyone. Everywhere.
For everyone. Everywhere.
Dates: Wed, Sep 7, 2022 – Sat, Sep 10, 2022
Location:
Manchester Central Convention Complex
Exchange Suite
Petersfield, Manchester, M2 3GX
Manchester, UK
Booth #36
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Distributed by Siemens Healthineers. CLINITEST Rapid COVID-19 Antigen Test: Not available for sale in the U.S.
This test 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.
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.
Fast Track Diagnostics assays are CE-marked for IVD use in the EU.
For research use only (RUO) in the U.S.
For Fast Track Diagnostics assays, please see the compatibility list to learn more about our compatible instruments. Customer is responsible for validating the assay on instruments listed in the compatibility list.
Product availability will vary country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.