Axis-Shield Diagnostics Limited

FDA Regulatory Profile

Axis-Shield Diagnostics Limited appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 2, 2019.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K183088ADVIA Centaur Erythropoietin (EPO) assayAugust 2, 2019
K182012ADVIA Centaur Calcitonin (CALCT) assayDecember 21, 2018
K153551ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and MasAugust 4, 2016
K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality CoJuly 26, 2016