Dec. 18, 2018—Siemens Healthineers has been granted 12 premarket approvals from the FDA for its infectious disease and oncology testing menu.
“These 12 PMA assays, combined with recently released High-Sensitivity Troponin I and Procalcitonin assays, provide a comprehensive menu on the Atellica Solution. Laboratories seeking a broad menu supporting the needs of their clinicians and patients can now find it on the Atellica Solution,” Deepak Nath, PhD, president of laboratory diagnostics at Siemens Healthineers, said in a statement.
The infectious disease tests new to the Atellica include HIV (HIV Ag/Ab Combo and HIV 1/O/2 Enhanced) and Hepatitis B and C (Anti-HBs 2, HBsAg II, HBsII Confirmatory, HBc IgM, HBc Total, HBeAg and HCV), and provide physicians with testing options for hepatitis screening, diagnosis, and monitoring.