Axis-Shield Diagnostics Limited - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
Axis-Shield Diagnostics Limited has 4 FDA 510(k) cleared medical devices. Based in Dundee, GB.
Historical record: 4 cleared submissions from 2016 to 2019. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Axis-Shield Diagnostics Limited Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Axis-Shield Diagnostics Limited
4 devices
Cleared
Aug 02, 2019
ADVIA Centaur Erythropoietin (EPO) assay
Hematology
269d
Cleared
Dec 21, 2018
ADVIA Centaur Calcitonin (CALCT) assay
Chemistry
147d
Cleared
Aug 04, 2016
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators,...
Immunology
237d
Cleared
Jul 26, 2016
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur...
Chemistry
130d