Item Brochure
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Unrestricted © Siemens Healthineers, 2021
We are committed to helping fight the world's most
threatening diseases.
In 2021, Siemens Healthineers launched two firsts into its portfolio in the fight against COVID-19…
FTD SARS-CoV-2 Real-Time PCR Assay
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For the specific detection of the novel coronavirus causing
COVID-19
The new FTD SARS-CoV-2 real time PCR Assay
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is now available for
molecular laboratories. A dual-target design for SARS-CoV-2
identification provides assay robustness and high sensitivity,
specificity, and inclusivity.
SARS-CoV-2 Total Antibody Assay
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Securing communities with science and scale
The SARS-CoV-2 Total Antibody assay
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detects both IgM and the
longer-lasting IgG antibodies in blood to help provide a clearer picture
of infection progression. An antibody test can reveal if a person had
COVID-19 even if they were asymptomatic or never diagnosed with
the disease.
https://www.siemens-healthineers.com/en-us/clinical-specialities/critical-care
1. These SARS-CoV-2 molecular and serology 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 serology 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.