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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 m
Immunoglobulin m
W0102010107
126 devices
Immunoglobulin M (IgM) Assay Kit (Immunonephelometric Method)
Shenzhen AmTech Bioengineering Ltd., Inc.
·
,
China
IVD General
CE/IVDD
IgM
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Immunoglobulin M
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
Optilite® Hevylite® IgM Kappa Control Pack
The Binding Site Group Ltd
·
,
United Kingdom
Class C
CE/IVDR
GUDID
on market
IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M Reagent
Beckman Coulter, Inc.
·
,
United States
Class B
FDA 510(k)
K993547
Active
Cleared 1 Feb 2000
CE/IVDR
+1
authorizations
IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
Optilite® IgM Control Pack
The Binding Site Group Ltd
·
,
United Kingdom
Class B
CE/IVDR
GUDID
on market
Immunoglobulin M Kit（immunoturbidimetric Method）
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Immunoglobulin M
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
Nephstar IgM Kit
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Optilite® Hevylite® IgM Kappa Kit
The Binding Site Group Ltd
·
,
United Kingdom
Class C
FDA 510(k)
K152389
Active
Cleared 18 Dec 2015
CE/IVDR
IgM
Biokit, S.A.
·
,
Spain
Class B
CE/IVDR
Immunoglobulin M (IgM)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
PRESTIGE 24i IgM
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
Immunoglobulin M (IgM) Assay Kit (Immunoturbidimetric Method)
Yhlo Biotech (Nanjing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Optilite® IgM CSF Control Pack
The Binding Site Group Ltd
·
,
United Kingdom
Class B
CE/IVDR
ACCENT-200 IgM
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
Immunoglobulin M (IgM) Kit(Immunoturbidimetric Method)
Zybio Inc.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
Immunoglobulin M Assay Kit (Immunoturbidimetric Method)
Da Te Bioengineering Technology Co., LTD.
·
,
China
IVD General
CE/IVDD
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