Medical Device Manufacturer · GB , Dundee

Axis-Shield Diagnostics Limited - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2016

Recent clearances: ADVIA Centaur Erythropoietin (EPO) assay, ADVIA Centaur Calcitonin (CALCT) assay, ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Axis-Shield Diagnostics Limited Chemistry ✕

2 devices

1-2 of 2

Cleared Dec 21, 2018

ADVIA Centaur Calcitonin (CALCT) assay

Chemistry · 147d

Cleared Jul 26, 2016

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur...

Chemistry · 130d