Nasal Swab Home Test Receives FDA Authorization
California-based ACON Laboratories, Inc. announced on October 4, 2021, that its Flowflex™ COVID-19 Antigen Home Test had been Authorized by the U.S. Food and Drug Administration (FDA).
This FDA Emergency Use Authorization will allow ACON to quickly respond to the unmet demand for simple and inexpensive home diagnostics as a critical tool in the fight against COVID-19.
Flowflex may be used for self-testing by individuals aged 14 years and older or with adult-collected nasal swabs from children as young as two years old.
The Flowflex COVID-19 Antigen Home Test is a simple nasal swab test available for purchase without a prescription.
In contrast to other home tests, which require testing twice within a two-to-three-day period (a process known as serial screening), the Flowflex COVID-19 Antigen Home Test has been authorized for use as a single test by individuals with or without symptoms.
Flowflex COVID-19 tests are available in many countries, including widespread distribution in the U.K. through the National Health Service.
Headquartered in San Diego, California, ACON's U.S. office centers strategic management, administration, business development, innovative research, and development. The Company's state-of-the-art manufacturing facility located in Hangzhou, China is ISO13485: 2016 certified, FDA registered and inspected by the FDA.