Alinity m SARS-CoV | 合法醫療器材資訊網
...ORDER#,GTIN.4x48AMPTray,4x48ACTTray,09N78-095,00884999049222...ORDER#,GTIN.12Positive,12Negative,09N78-085,00884999049208 ...
INTENDED USE
The Alinity m SARS-CoV-2 assay is a real-time reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in mid-turbinate nasal, anterior nasal, nasopharyngeal (NP) and oropharyngeal (OP) swabs, and bronchoalveolar lavage (BAL) specimens collected from individuals suspected of COVID-19 by their healthcare provider (HCP), as well as mid-turbinate nasal, anterior nasal, NP and OP swabs collected from any individual, including individuals without symptoms or other reasons to suspect COVID-19 infection. Testing of non-pooled specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, that meet requirements to perform moderate or high complexity tests.
This test ...
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器材品名:亞培樣本製備系統(未滅菌)許可證字號:衛署醫器輸壹字第004139號註銷狀態:已註銷註銷日期:2016/04/18註銷理由:不以...
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