Axis-Shield Diagnostics, Ltd. - FDA 510(k) Cleared Devices
24
Total
24
Cleared
0
Denied
FDA 510(k) cleared devices by Axis-Shield Diagnostics, Ltd. Chemistry ✕
14 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
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
Cleared
Mar 17, 2008
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
Chemistry
175d
Cleared
Nov 22, 2006
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20
Chemistry
90d
Cleared
Sep 29, 2004
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
Chemistry
82d
Cleared
Jan 30, 2004
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME...
Chemistry
74d