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In vitro diagnostic medical devices
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Reagents
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Immunochemistry (immunology)
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Specific proteins
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Immunoglobulins (except ige)
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Immunoglobulin a
Immunoglobulin a
W0102010101
129 devices
EliA IgA Calibrator Well
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
Immunoglobulin A
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A Reagent
Beckman Coulter, Inc.
·
,
United States
IVD General
FDA 510(k)
×3
K060130
Active
Cleared 13 Feb 2006
CE/IVDD
+1
authorizations
Immune Globulin A (IgA) Test Kit (Immunoturbidimetric)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Iga
Medicon Hellas SA
·
,
Greece
Class B
CE/IVDR
Immune Globulin A (IgA) Test Kit (Immunoturbidimetric)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Immunoglobulin A (IgA) Assay kit (Immunoturbidimetric Method)
Shenzhen AmTech Bioengineering Ltd., Inc.
·
,
China
IVD General
CE/IVDD
sIgA
Neomedica Doo Niš
·
,
Serbia
IVD General
CE/IVDD
Immunoglobulin A
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
Immunoglobulin A (IgA)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
A-400 IgA
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
Immunoglobulin A (IgA) Detection Kit (Nephelometry)
Genrui Biotech Inc.
·
,
China
IVD General
CE/IVDD
Immunoglobulin A (IgA)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
ACCENT-200 IgA
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
IMMUNOGLOBULIN A (IgA)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Immunoglobulin (IgA/IgG/IgM) Reagent Kit
Changsha Sinocare Inc.
·
,
China
IVD General
CE/IVDD
Immunoglobulin Isotypes (GAM) for the EXENT® Analyser
Open recall
The Binding Site Group Ltd.
·
,
United Kingdom
Class C
FDA 510(k)
K250159
Active
Cleared 17 Oct 2025
CE/IVDR
EXENT® Immunoglobulin Isotypes (GAM) Control Pack
The Binding Site Group Ltd
·
,
United Kingdom
Class C
CE/IVDR
GUDID
on market
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