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Celiac disease
Celiac disease
W01021006
137 devices
Subcategories
5
W0102100601
Tissue transglutaminase antibodies
46
devices
W0102100602
Tissue transglutaminase/ gliadin antibodies combitest
26
devices
W0102100603
Antibodies to endomysial autoantigenes
11
devices
W0102100604
Gliadin antibodies
38
devices
W0102100699
Celiac disease - other
16
devices
Devices
BioCLIA Autoimmune Reagent Kit, human tTG IgA
HOB Biotech Group Corp., Ltd.
·
,
China
IVD General
CE/IVDD
ANTI-tTRANSGLUTAMINASE ANTIBODIES IgG (ANTI-tTG IgG)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
BIOHIT Celiac quick test
Biohit Oyj
·
,
Finland
IVD General
CE/IVDD
anti-human epidermal transglutaminase IgA (anti-heTG IgA) ELISA
Immundiagnostik AG
·
,
Germany
IVD General
CE/IVDD
BlueWell Deamidated Gliadin IgA ELISA
D-tek s.a.
·
,
Belgium
IVD General
CE/IVDD
DIASpot Celiac IgA
D-tek s.a.
·
,
Belgium
Class B
CE/IVDR
BlueDiver Dot Celiac IgA
D-tek s.a.
·
,
Belgium
IVD General
CE/IVDD
Aptiva Celiac Disease IgG Reagent
Inova Diagnostics, Inc.
·
,
United States
Class B
CE/IVDD
FDA 510(k)
K200230
Active
Cleared 26 Aug 2021
+2
authorizations
BlueDot Celiac IgG
D-tek s.a.
·
,
Belgium
IVD General
CE/IVDR
CE/IVDD
BlueDiver Dot Celiac IgG
D-tek s.a.
·
,
Belgium
IVD General
CE/IVDD
Gliadin-tTransglutaminase IgA Dot
D-tek s.a.
·
,
Belgium
Class B
CE/IVDR
BlueWell Transglutaminase IgG ELISA
D-tek s.a.
·
,
Belgium
IVD General
CE/IVDD
Gliadin- tTransglutaminase IgA Dot for BDI
D-tek s.a.
·
,
Belgium
Class B
CE/IVDR
Blocard ™ Celiac Test
Labsystems Diagnostics Oy
·
,
Finland
IVD General
CE/IVDD
Biocard™ Celiac Home
Labsystems Diagnostics Oy
·
,
Finland
IVD for self-testing
CE/IVDD
Gliadin-tTransglutaminase IgG Dot
D-tek s.a.
·
,
Belgium
Class B
CE/IVDR
DIASpot Neptune Celiac IgA
D-tek s.a.
·
,
Belgium
Class B
CE/IVDR
Gliadin- tTransglutaminase IgG Dot for BDI
D-tek s.a.
·
,
Belgium
Class B
CE/IVDR
BlueDot Celiac IgA
D-tek s.a.
·
,
Belgium
IVD General
CE/IVDD
BlueWell Transglutaminase IgA ELISA
D-tek s.a.
·
,
Belgium
IVD General
CE/IVDD
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