BioGX now holds a Certificate of Registration for Quality Management System (QMS)- ISO 13485;2003 (Certificate No FM 642714) and now operates a QMS which complies with the requirements of ISO 13485;2003 for “the design, development, manufacture and distribution of in-vitro diagnostics and contract specified reagents for molecular diagnostics.
This Fact Sheet informs you of the significant known and potential risks and benefits of the use of the BioGX Xfree™ COVID-19 Direct RT-PCR.
The BioGX Xfree™ COVID-19 Direct RT-PCR is validated for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
Download the required Direct Sample Run Files and associated PDFsQuantStudio™ 5 Direct Sample Run File
QuantStudio™ 5 Direct Sample PDF
CFX96 Touch™ Direct Sample Run File 1
CFX96 Touch™ Direct Sample Run File 2
CFX96 Touch™ Direct Sample PDF
