AlphaDERA Labs FDA Emergency Use Authorization for COVID-19 RT-PCR Test
July 24, 2023
AlphaDERA Labs obtained Emergency Use Authorization from the US Food and Drug Administration last week for a PCR assay to detect SARS-CoV-2.
The assay, named Alphadx SARS-CoV-2 RT-PCR Test, is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and mid-turbinate nasal swab specimens from individuals suspected of having COVID-19 by their healthcare provider.
Testing is limited to AlphaDERA's CLIA facility, which is authorized to perform high-complexity testing, according to the FDA's letter of authorization.
Based in Houston, AlphaDERA offers COVID-19 testing for healthcare providers, travelers, individual patients, and public or private organizations, according to the company’s website.
AlphaDERA Labs - Precision in Diagnostics, Trusted by Professionals
AlphaDERA Labs is a certified name when it comes to clinical lab testing and diagnostic services. Since our inception in 2018, we have been at the forefront of innovation, delivering accurate and reliable results and helping professionals, individuals, and communities make informed health decisions. Our commitment to excellence has positioned us as a trusted partner in the field of laboratory services.
