DiaSorin, Inc. - FDA 510(k) Cleared Devices
70
Total
69
Cleared
1
Denied
41 devices
Cleared
Dec 05, 2008
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
Microbiology
140d
Cleared
Nov 21, 2008
DIASORIN LIASON RUBELLA IGG ASSAY
Microbiology
354d
Cleared
Nov 18, 2008
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
Microbiology
154d
Cleared
Nov 10, 2008
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
Microbiology
146d
Cleared
Nov 03, 2008
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
Microbiology
108d
Cleared
Apr 12, 2007
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870
Microbiology
231d
Cleared
Feb 26, 2007
DIASORIN LIAISON VZV IGG
Microbiology
243d
Cleared
Oct 18, 2006
LIAISON EA IGG
Microbiology
265d
Cleared
Jul 31, 2006
DIASORIN LIAISON TREPONEMA ASSAY
Microbiology
89d
Cleared
Apr 29, 2005
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
Microbiology
465d
Cleared
Feb 10, 2000
COPALIS RUBELLA IGM
Microbiology
132d
Cleared
Dec 16, 1999
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
Microbiology
139d
Cleared
Jul 12, 1999
ETI-EA-G ASSAY
Microbiology
14d
Cleared
Jun 04, 1999
COPALIS MULTIPLEX EBV ANTIBODY ASSAY
Microbiology
21d
Cleared
May 14, 1999
COPALIS EBV-M ANTIBODY ASSAY
Microbiology
18d
Cleared
Nov 25, 1998
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
Microbiology
176d