Our device is solely intended to be used by healthcare professionals
As a healthcare manufacturer, Fluxergy must abide by strict national/international regulations regarding the usage and sale of our platform. This can make things a tad confusing for our customers. Here’s it simplified–
Fluxergy has recently obtained CE marking for our one-hour COVID-19 RT-PCR test, for use by human healthcare professionals as an in-vitro diagnostics (IVD) for the detection of SARS-CoV-2. The CE-mark allows Fluxergy’s innovative testing platform to enter the European Union market and any other markets that accept CE-marking as valid regulatory approval.
In December 2020, Fluxergy also recieved dual ISO-13485:2016* and MDSAP** certifications. We are currently starting the process for USDA and AOAC regulatory approvals for ASRs and assay kits that can impact the veterinary and food safety industries.
*The ISO 13485:2016 is the medical device industry’s most widely used international standard for quality management systems to design, develop, produce, and deliver products.
**MDSAP certification satisfies the quality system requirements of the regulatory authorities participating in the program, including the U.S. FDA, Health Canada, Brazil’s Agência Nacionalde Vigilância Sanitária and Australia’s Therapeutic Goods Administration.