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Product Certification

  • Patent granted in major countries around the world (United States, China, European Union, Japan, Australia, India, Singapore)

  • IEC 61010 product safety certification and IEC 61326-2-6:2020 electromagnetic safety certification from TUV

  • FDA emergency authorization for COVID-19 RT-qPCR Assay on XDive

  • FDA emergency authorization for SalivaDirect COVID-19 Assay on XDive

  • FDA emergency authorization for MonkeyPox COVID-19 Assay on XDive

  • ISO13485 production facility, including IVD equipment, consumables, IVD reagents and IVD infectious disease diagnostic kits

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