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Tissue transglutaminase/ gliadin antibodies combitest
Tissue transglutaminase/ gliadin antibodies combitest
W0102100602
26 devices
Devices
BlueWell Deamidated Gliadin IgA ELISA
D-tek s.a.
·
,
BE
IVD General
CE/IVDD
DIASpot Celiac IgA
D-tek s.a.
·
,
BE
Class B
CE/IVDR
BlueDiver Dot Celiac IgA
D-tek s.a.
·
,
BE
IVD General
CE/IVDR
CE/IVDD
Aptiva Celiac Disease IgG Reagent
Inova Diagnostics, Inc.
·
,
US
Class B
FDA 510(k)
K200230
Active
Cleared 26 Aug 2021
CE/IVDD
+2
authorizations
BlueDot Celiac IgG
D-tek s.a.
·
,
BE
IVD General
CE/IVDR
CE/IVDD
BlueDiver Dot Celiac IgG
D-tek s.a.
·
,
BE
IVD General
CE/IVDD
Gliadin-tTransglutaminase IgA Dot
D-tek s.a.
·
,
BE
Class B
CE/IVDR
BlueWell Transglutaminase IgG ELISA
D-tek s.a.
·
,
BE
IVD General
CE/IVDD
Gliadin- tTransglutaminase IgA Dot for BDI
D-tek s.a.
·
,
BE
Class B
CE/IVDR
Blocard ™ Celiac Test
Labsystems Diagnostics Oy
·
,
FI
IVD General
CE/IVDD
Biocard™ Celiac Home
Labsystems Diagnostics Oy
·
,
FI
IVD for self-testing
CE/IVDD
Gliadin-tTransglutaminase IgG Dot
D-tek s.a.
·
,
BE
Class B
CE/IVDR
DIASpot Neptune Celiac IgA
D-tek s.a.
·
,
BE
Class B
CE/IVDR
Gliadin- tTransglutaminase IgG Dot for BDI
D-tek s.a.
·
,
BE
Class B
CE/IVDR
BlueDot Celiac IgA
D-tek s.a.
·
,
BE
IVD General
CE/IVDR
CE/IVDD
BlueWell Transglutaminase IgA ELISA
D-tek s.a.
·
,
BE
IVD General
CE/IVDD
BlueWell Deamidated Gliadin IgG ELISA
D-tek s.a.
·
,
BE
IVD General
CE/IVDD
DIASpot Celiac IgG
D-tek s.a.
·
,
BE
Class B
CE/IVDR
DIASpot Neptune Celiac IgG
D-tek s.a.
·
,
BE
Class B
CE/IVDR
Aptiva Celiac Disease IgA Reagent
Inova Diagnostics, Inc.
·
,
US
Class B
FDA 510(k)
K193604
Active
Cleared 16 Jun 2021
CE/IVDR
+1
authorizations
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