Chembio Diagnostics’ Zika Test Gains 510(k) Clearance

Chembio Diagnostics has received 510(k) clearance from the FDA for its Dual-Path Platform (DPP) Zika IgM antibody test for the Zika virus.

Immunoglobulin M antibodies are typically found in blood samples within four days of the onset of symptoms and they remain detectable for at least 12 weeks.

The clearance also covers the DPP Micro Reader, a handheld, portable analyzer that handles all Chembio DPP tests. It delivers results for the Zika test in about 15 minutes.