Great News! Our SARS-CoV-2 Test Kit Has Obtained US FDA EUA Certification!


Great News! Our SARS-CoV-2 Test Kit Has Obtained US FDA EUA Certification!

The SARS-CoV-2 Test Kit developed by our company was officially certified by the FDA EUA on May 22nd, announced by the FDA official website. This means that our product has received a “pass” in the US market and can be rolled out for large-scale testing in CLIA Medical Certification Laboratories across the United States.


We are the first Chinese company to receive the FDA EUA certification in the past month, the fifth enterprise in China that has obtained the US FDA EUA, and the only enterprise that has no overseas-affiliated companies to be approved by the FDA.

“[Before the outbreak of the novel coronavirus,] our company had no business relations with SpectronRX Pharmaceutical Company of the United States,” said CEO Dr. Tammy Tan. “It was [after the outbreak of COVID-19 in the United States] that SpectronRX actively contacted us after learning relevant information from the internet and other channels, that they contacted us and offered to cooperate with us. After some negotiations, we authorized them to represent our Hymon® SARS-CoV-2 Test Kit, which was developed and produced by us, in North America.”

John Zehner, CEO of SpectronRX Pharmaceuticals, wrote to our company, “The COVID-19 epidemic continues to test and challenge the US medical system. We need diversified measures to combat the virus. The Hymon® SARS-CoV-2 Test Kit has the advantage of being fast, simple, and accurate. It can be deployed in more than 7000 CLIA medically-certified laboratories across the United States for large-scale testing.”

In the future, we will join hands with SpectronRX Pharmaceutical Company to continue providing patients and doctors with unique value in the field of diagnosis and treatment of major diseases.

Post time: May-29-2020