ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

K191578 is the FDA 510(k) clearance record for ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control, a class II device, cleared for Siemens Healthcare Diagnostics, Inc. on 2019-07-17 under FDA product code QFO (Zika Virus Serological Reagents). FDA's definition for product code QFO reads: "Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection...". FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, Inc., from 1976-10-29 to 2026-08-10. As of 2026-09-10, FDA records show no recalls naming K191578.