ZEUS ELISA SARS-CoV | 合法醫療器材資訊網
...COVID-19underSection564(b)(1)oftheFood,DrugandCosmeticAct,21U.S.C.§360bbb-3(b)(1),unlesstheauthorizationisterminatedorrevokedsooner.
Back[1]Intended Use
The ZEUS ELISA SARS-CoV-2 IgG Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma (dipotassium EDTA, lithium heparin and sodium citrate) run manually or using the Dynex AGILITY, Dynex DSX or Dynex DS2 automated ELISA Systems. The ZEUS ELISA SARS-CoV-2 IgG Test System is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
Results are for the detection of SARS CoV-2 antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, a...
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【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...