09/09/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 9/9/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the BioCheck SARS-CoV-2 IgG Antibody Test Kit. The BioCheck SARS-CoV-2 IgG Antibody Test Kit is authorized for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum. (PDF)
09/09/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 9/9/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Wantai SARS-CoV-2 RT-PCR Kit. The Wantai SARS-CoV-2 RT-PCR Kit is authorized for use with oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. (PDF)
09/08/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 9/8/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Verily COVID-19 RT-PCR Test. The Verily COVID-19 RT-PCR Test is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. (PDF)
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