Axis-Shield Diagnostics Limited
Axis-Shield Diagnostics Limited holds FDA 510(k) medical device clearances, first cleared 2016, most recent 2019.
Top product codes for Axis-Shield Diagnostics Limited
Recent clearances by Axis-Shield Diagnostics Limited
- K183088 — ADVIA Centaur Erythropoietin (EPO) assay
- K182012 — ADVIA Centaur Calcitonin (CALCT) assay
- K153551 — ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
- K160757 — ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
Data sourced from openFDA. This site is unofficial and independent of the FDA.