Reagent Kit QIAstat-Dx® Molecular Diagnostic Respiratory SARS-CoV-2 Panel For use with QIAstat-Dx Instrument 6 Tests

For in vitro diagnostic use under Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

Intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures

Multiplex syndromic cartridge detects and differentiates 21 respiratory targets, including SARS-CoV-2 from nasopharyngeal swabs (NPS) eluted in universal transport media (Enterovirus and Rhinovirus are both detected, but not differentiated)

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform high complexity and moderate complexity tests

Please review the documents under the More Information tab prior to purchasing

Link to FDA site: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

All reagents required for the complete execution of a test run are pre-loaded and self-contained in the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge

Kit includes: (6) Individually packaged cartridges containing all reagents needed for sample preparation and multiplex real-time RTPCR, plus Internal Control, and (6) individually packaged transfer pipettes for dispensing liquid sample into the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge

Intuitive workflow with less than one-minute hands-on time

All wet and dry reagents onboard and room temperature stable

Comprehensive qualitative results available in about an hour