Home » Co-Diagnostics’ IVD for Tuberculosis Gets CE Mark
Co-Diagnostics’ IVD for Tuberculosis Gets CE Mark
Devices Submissions and Approvals
Co-Diagnostics received a CE Mark for its Logix Smart MTB test, an in vitro diagnostic for diagnosing tuberculosis.
Tuberculosis was listed by the World Health Organization as one of the top ten causes of death globally. The disease often shows no early symptoms, leading to late diagnosis that can prove fatal.
The company is not currently seeking FDA approval for the IVD, as the U.S. has a low domestic rate of tuberculosis incidents.