Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Axis-Shield Diagnostics, Ltd.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest FDA decision2026-02-18
TypeNumberDevice NameCodeDateActions
510(k) K253539 Alere NT-proBNP for Alinity iNBC2026-02-18 View
510(k) K241176 Alere NT-proBNP for Alinity i Reagent KitNBC2025-01-16 View
510(k) K233541 ARCHITECT Active-B12 (Holotranscobalamin)CDD2024-07-31 View
510(k) K172133 ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCDD2017-10-27 View
↑