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In vitro diagnostic medical devices
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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 Conjugate 200
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
Optilite® Hevylite® IgA Lambda Kit
The Binding Site Group Ltd
·
,
United Kingdom
Class C
CE/IVDR
Immunoglobulin A (IgA)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Immunoglobulin A Test Kit (Immunoturbidimetric Assay)
URIT Medical Electronic Co., Ltd.
·
,
China
IVD General
CE/IVDD
CORMAY IgA
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
Optilite® Hevylite® IgA Kappa Kit
The Binding Site Group Ltd
·
,
United Kingdom
Class C
FDA 510(k)
K160819
Active
Cleared 16 Jun 2016
CE/IVDR
Immunoglobulin A (IgA) Assay Kit (Immunoturbidimetric Method)
Yhlo Biotech (Nanjing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
INMUNOGLOBULINA A (IgA)
Quimica Clinica Aplicada S.A.
·
,
Spain
IVD General
CE/IVDD
Immunoglobulin A (IgA)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
AESKUCARE® Gluten Related Disorders IgA
AESKU.DIAGNOSTICS GmbH&Co.KG
·
,
Germany
IVD General
CE/IVDD
EliA IgA Conjugate 50
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
Evo Autoimmune A
Abd SRL
·
,
Italy
Class A
CE/IVDR
Immunoglobulin A Kit (Turbidimetry Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
IgA
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Immunoglobulin A Assay Kit (Immunoturbidimetric Method)
Da Te Bioengineering Technology Co., LTD.
·
,
China
IVD General
CE/IVDD
Optilite® Hevylite® IgA Lambda Control Pack
The Binding Site Group Ltd
·
,
United Kingdom
Class C
CE/IVDR
GUDID
on market
Immunoglobin A Kit (Immunoturbidimetric Method)
Medicalsystem Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Immunoglobulin A Kit (Immunoturbidimetric Method)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Iga
Medicon Hellas SA
·
,
Greece
Class B
CE/IVDR
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