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  4. Siemens Healthineers Now Shipping Worldwide Total Antibody Test and Molecular Test Kit for COVID-19 with Expanded Capacity
Press release

Siemens Healthineers Now Shipping Worldwide Total Antibody Test and Molecular Test Kit for COVID-19 with Expanded Capacity

Published on May 26, 2020

Siemens Healthineers now shipping worldwide Total Antibody Test and Molecular Test Kit for COVID-19 with expanded capacity. On the image you see the Total Antibody Test.
Siemens Healthineers now shipping worldwide Total Antibody Test and Molecular Test Kit for COVID-19 with expanded capacity. On the image you see the Total Antibody Test.

Total Antibody Test At a Glance

Download this press release(pdf, 84.58 KB)
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CE-marked for sale in the EU. This test has not been reviewed by the FDA. In the US, use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary by country and is subject to regulatory requirements.

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≥ 14 days post-PCR positive test

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Product claims, including intended use, are applicable to the CE-marked assay. These claims have not been authorized by FDA.

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Dependent upon test mix.

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Under development. Not available for sale. Future availability cannot be guaranteed.

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CE-marked for sale in the EU. 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 nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. 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. Product availability may vary by country and is subject to regulatory requirements.

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In method comparison studies, FTD SARS-CoV-2 has shown Positive Percent Agreement: 100% (91.8-100, 95% CI) and Negative Percent Agreement: 100% (88.7-100, 95% CI) when tested in Copan eSwab nasopharyngeal and oropharyngeal swabs.

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CE-marked for sale in the EU. Research Use Only (RUO) in the U.S.

Siemens Healthineers 2020

Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalising healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostics, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care to patients. In fiscal 2020, which ended on September 30, 2020, Siemens Healthineers, which has approximately 54,000 employees worldwide, generated revenue of €14.5 billion and adjusted EBIT of €2.2 billion.