ZEUS Scientific Announces FDA EUA Approval for ZEUS ... | 合法醫療器材資訊網
2021年5月17日—PRNewswire/--ZEUSScientificannouncedtodaythatithas...totheSARS-CoV-2(novel2019)Coronavirusinhumanserumandplasma.
BRANCHBURG, N.J., May 17, 2021 /PRNewswire/ -- ZEUS Scientific announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its in vitro ELISA diagnostic test for the qualitative detection of total (IgG/IgM/IgA) antibodies to the SARS-CoV-2 (novel 2019) Coronavirus in human serum and plasma. This test is in stock and is readily available to all clinical laboratories.
The ZEUS ELISA SARS-CoV-2 Total Test System[1] is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The assay utilizes a dual antigen combination of recombinant S1 receptor binding domain (RBD) viral protein and recombinant nucleoprotein for optimal performance. By detecting a total antibody response to both the Nucleocapsid and Spike SARS-CoV-2 antigens the tes...
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ZEUS Scientific Announces FDA EUA Approval for ZEUS ... | 合法醫療器材資訊網
【宙斯第一型單純皰疹病毒IgG抗體試驗系統】許可證字號:衛部醫器輸字第027895號
器材品名:宙斯第一型單純皰疹病毒IgG抗體試驗系統許可證字號:衛部醫器輸字第027895號註銷狀態:註銷日期:註銷理由:有效日期:2...