FDA Approval
Detection of BK virus in urine may be indicative of early infection in immunocompromised transplant patients Early detection is critical as complications due to infection after transplantation are one of the main causes of...
Health and Human Services (HHS) is seeking public comments on making permanent regulatory flexibilities provided during the COVID–19 public health emergency by exempting certain medical devices from premarket notification requirements;...
Roche receives FDA Emergency Use Authorization for the cobas SARS-C...
MEDIA RELEASE First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample As COVID-19 and influenza infections can hardly...
Roche Receives FDA Approval for First HIV-1/HIV-2 Qualitative Test ...
MEDIA RELEASE Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV — from appropriate counseling on disease differences to...
