On 28 October 2022, Credo Diagnostics Biomedical received confirmation from the UK Health Security Agency that the VitaPCR™ SARS-CoV-2 Gen 2 Assay has been approved under the requirements set out in The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021.
VitaPCR™ SARS-CoV-2 Gen 2 Assay is a rapid molecular in-vitro diagnostic solution, using real-time reverse transcription polymerase chain reaction (rRT-PCR) amplification technology for the qualitative detection of SARS-CoV-2 in patients’ nasopharyngeal swabs.
VitaPCR™ SARS-CoV-2 Gen 2 system is easy to use and portable to deploy anywhere. This solution delivers accurate results in 20 minutes, allowing healthcare professionals to provide patients with the right course of treatment in a timely manner.
Dr. Wong Jr. Winston, Chairman and CEO of Credo Diagnostics Biomedical, said, “We are honored to receive the UK CTDA approval for our VitaPCR™ SARS-CoV-Gen 2 Assay. This significant milestone further reinforces our commitment to our mission of providing advanced medical technology for all. This accomplishment could not have been possible without the hard work and dedication of the team at Credo Diagnostics Biomedical. Together with our distribution network for VitaPCR™, we are ready for expansion into the UK market, bringing accessible diagnostics solutions to improve lives.”
For more information, contact us at service@credodxbiomed.com.
