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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Markers for auto-immune diseases
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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
BlueWell Deamidated Gliadin IgG ELISA
D-tek s.a.
·
,
Belgium
IVD General
CE/IVDD
DIASpot Celiac IgG
D-tek s.a.
·
,
Belgium
Class B
CE/IVDR
DIASpot Neptune Celiac IgG
D-tek s.a.
·
,
Belgium
Class B
CE/IVDR
Aptiva Celiac Disease IgA Reagent
Inova Diagnostics, Inc.
·
,
United States
Class B
FDA 510(k)
K193604
Active
Cleared 16 Jun 2021
CE/IVDR
+1
authorizations
BlueWell Endomysium IgA ELISA
D-tek s.a.
·
,
Belgium
IVD General
CE/IVDD
Anti-Endometrium IgM Assay Kit(Chemiluminescent Microparticle Immunoassay)
URIT Medical Electronic Co., Ltd.
·
,
China
IVD General
CE/IVDD
NOVA Lite
Inova Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Anti-Endomysium Antibodies (Aea)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Anti-Endomysium Antibodies (Aea)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Anti-Endomysium Antibodies (Aea)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Anti-Endomysium Antibodies (Aea)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Anti-Endomysium Antibodies (Aea)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
NOVA Lite
Inova Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Anti-Endomysium Antibodies (Aea)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
NOVA Lite
Inova Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Anti-Endomysium Antibodies (Aea)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
IDK® anti-human neuronal transglutaminase IgA (anti-hnTG IgA) ELISA
Immundiagnostik AG
·
,
Germany
IVD General
CE/IVDD
Anti-gliadin sIgA / IgA in stool ELISA (960 tests)
ImmuChrom GmbH
·
,
Germany
IVD General
CE/IVDD
IDK® anti-human neuronal transglutaminase IgG (anti-hnTG IgG) ELISA
Immundiagnostik AG
·
,
Germany
IVD General
CE/IVDD
BIOSYNEX Autotest Gluten
Biosynex
·
,
France
IVD for self-testing
CE/IVDD
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