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. Immunology ✕
10 devices
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
Mar 20, 2007
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20,...
Immunology
134d
Cleared
Jun 19, 2003
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
Immunology
66d
Cleared
Oct 09, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
Immunology
23d
Cleared
Jul 23, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
Immunology
74d
Cleared
May 02, 2002
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING...
Immunology
87d
Cleared
May 02, 2002
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
Immunology
87d
Cleared
May 02, 2002
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
Immunology
59d
Cleared
Mar 06, 2002
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
Immunology
48d