Diagnostics for the Real World (DRW) is pleased to announce that its SAMBA III SARS-CoV-2 Test and SAMBA III SCoV-2/Flu/RSV Test have received approval under the UK Coronavirus Test Device Approvals (CTDA) process. Following a successful desktop review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), both assays have been approved under Regulation 38A(5) of the Medical Device Regulations 2002 and will be listed on the UK register of approved COVID-19 test validation products.
The SAMBA III respiratory assays form part of DRW’s expanding menu of molecular tests, reflecting the company’s ongoing commitment to providing innovative diagnostic solutions that address real-world clinical challenges.