Nuclein

The DASH® Rapid PCR System, is a point-of-care (POC) in vitro diagnostic (IVD) that detects nucleic acids of target pathogens. The first test for the DASH® Rapid PCR System is the FDA-cleared, CLIA-waived DASH® SARS-CoV-2 & Flu A/B Test. The system consists of an instrument, barcode scanner, collection swabs, and test cartridges.

The DASH® Rapid PCR System delivers lab-quality results at the point of care, is simple to use, and can be operated with minimal training..

Assistance provided:

  • IEC 62304 Software compliance

  • Risk Management Plan & Report

  • Preliminary Hazard Analysis

  • Hazard Analysis

  • Design FMEAs

  • FDA Cybersecurity compliance

  • Usability Engineering File

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