Axis-Shield Diagnostics, Ltd. - FDA 510(k) Cleared Devices
24
Total
24
Cleared
0
Denied
Axis-Shield Diagnostics, Ltd. has 24 FDA 510(k) cleared medical devices. Based in Dundee, GB.
Latest FDA clearance: Feb 2026. Active since 2002. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Axis-Shield Diagnostics, Ltd. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Axis-Shield Diagnostics, Ltd.
24 devices
Cleared
Feb 18, 2026
Alere NT-proBNP for Alinity i
Chemistry
97d
Cleared
Jan 16, 2025
Alere NT-proBNP for Alinity i Reagent Kit
Chemistry
262d
Cleared
Jul 31, 2024
ARCHITECT Active-B12 (Holotranscobalamin)
Chemistry
271d
Cleared
Oct 27, 2017
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
Chemistry
105d
Cleared
Mar 22, 2013
AXIS-SHIELD ACVTIVE-B12
Chemistry
262d
Cleared
Dec 12, 2012
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
Chemistry
170d
Cleared
May 07, 2012
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
Chemistry
224d
Cleared
Dec 19, 2011
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
Chemistry
117d
Cleared
Aug 18, 2011
AXIS-SHIELD ANTI-CCP
Immunology
198d
Cleared
Sep 25, 2009
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25,...
Immunology
270d
Cleared
Jul 31, 2009
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
Chemistry
270d
Cleared
Apr 24, 2008
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
Chemistry
120d