Qiagen QIAstat-Dx Analyzer

उत्पाद वर्णन

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The QIAstat-Dx Analyzer and the QIAstat-Dx Respiratory Panel are intended for in vitro diagnostic use.

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for in vitro diagnostic use under Emergency Use Authorization Only. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity and moderate complexity tests.

The QIAstat-Dx Respiratory SARS-CoV-2 Panel has not been FDA cleared or approved;

The QIAstat-Dx Respiratory SARS-CoV-2 Panel has been authorized by FDA under an EUA for use by authorized laboratories

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