ARIES® SARS-CoV | 合法醫療器材資訊網
TheARIES®SARS‑CoV‑2Assay(EUA)isareal-timePCR-basedinvitrodiagnostictestthatdetectsSARS‑CoV‑2nucleicacidinnasopharyngealswab(NPS) ...
The ARIES® SARS-CoV-2 Assay is a real-time reverse-transcriptase polymerase chain reaction (RT-PCR)-based in vitro diagnostic test intended for the qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate- and high-complexity tests.
Results are for the identification of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infectio...
ARIES-system | 合法醫療器材資訊網
ARIES® HSV 1&2 ASSAY (RUO) | 合法醫療器材資訊網
ARIES® Molecular Diagnostics Platform | 合法醫療器材資訊網
ARIES® Norovirus Assay | 合法醫療器材資訊網
ARIES® SARS-CoV | 合法醫療器材資訊網
ARIES® User Defined Protocol (UDP) Capability | 合法醫療器材資訊網
Manual, ARIES System Operation (IVD) | 合法醫療器材資訊網
【“路明克斯”愛維思即時偵測PCR分析儀】許可證字號:衛部醫器輸字第030539號
器材品名:“路明克斯”愛維思即時偵測PCR分析儀許可證字號:衛部醫器輸字第030539號註銷狀態:註銷日期:註銷理由:有效日期:2023/...