China's Best One-Stop Medical Equipment Provider
About

The First To Know® Syphilis Test is the first and only Over-the-Counter test for the detection of antibodies to the bacteria that cause syphilis. It provides an accurate, in-home result in 15 minutes with a single drop of blood and is easy to use, empowering everyone to take control of their health and be the first to know. The test received marketing authorization from the FDA through the de novo pathway, recognizing it as a novel device for syphilis testing in the United States, distinguishing it from other products on the market. Syphilis infections have surged to epidemic levels, heights not seen since the 1950s. This alarming trend underscores the critical need for accessible and reliable testing solutions. Syphilis can lead to serious health complications if left untreated. One of the challenges in combating syphilis is that it often does not present noticeable symptoms, making regular testing crucial for those at risk. The First To Know® Syphilis Test addresses this urgent public health need by enabling access to convenient, private and accurate testing with results in minutes. *Learn more at www.firsttoknow.com.

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Keywords
medical equipment manufacturing disease screening at-home syphilis testing fda de novo clearance public health screening tools blood separation microfluidics medical equipment and supplies manufacturing blood-based immunoassays public health impact d2c blood testing technology home health testing blood sample separation quality manufacturing 15-minute results self-administered blood tests b2c retail infectious disease diagnostics fda marketing authorization digital health integration healthcare innovation lay user testing immunological assay technology rapid in-home testing health testing & diagnostics blood sample collection public health testing microfluidics patented immunoassay
Company Information
  • Employees 0
  • Founded 2024
  • Annual Revenue $10000000
Location

2913 El Camino Real, Tustin, California, United States, 92782-8909

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