Quidel M5301 - Molecular Diagnostic… | USA MedPremium
Molecular Diagnostic Control SARS-CoV-2 Positive Level for Solana Assay
USAMP#98128353SKU: M5301Quidel
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Designed for use under FDA Emergency Use Authorization, ensuring compliance with current regulatory standards: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
Applicable for laboratories certified under CLIA to perform high or moderate complexity tests, expanding its usability within professional settings.
Employs an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) technique, offering precise and reliable SARS-CoV-2 detection.
Requires refrigeration for storage, maintaining the integrity of the assay for consistent results.
