SARS-CoV-2 Fluorescent PCR Kit of Maccura obtained the FDA's EUA
On April 15, the SARS-CoV-2 Fluorescent PCR Kit of Maccura obtained the FDA's EUA (Emergency Use Authorization).
The FDA received the EUA declaration of the SARS-CoV-2 Fluorescent PCR Kit from Maccura on March 11 and officially accepted it. The EUA data review was completed on March 24, and the authorization was formally issued on April 15.
SARS-CoV-2 Fluorescent PCR Kit of Maccura is designed for triple-targets, it can better avoid the missed detection of SARS-CoV-2. At the same time, internal standards are added to prevent false negative test results. Clinical tests have shown that the kit has good performance, high sensitivity and specificity. And the test takes relatively short time, and can complete 96 tests within 2 hours.
The approved SARS-CoV-2 Fluorescent PCR Kit has previously obtained the medical device registration certificate issued by the National Medical Products Administration (NMPA) and obtained the CE certification, which will provide high-quality testing products and services around the world. Also, it will assist in the prevention and control of global outbreaks.
Source： Maccura https://www.maccura.com/en/news/WwgA7UmFXAE-.html