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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
Devices
EliA IgM Calibrator Well
Phadia AB
·
,
SE
Class B
CE/IVDR
GUDID
on market
INMUNOGLOBULINA M (IgM)
Quimica Clinica Aplicada S.A.
·
,
ES
IVD General
CE/IVDD
Immunoglobulin M Assay Kit (Immunoturbidimetric Method)
Da Te Bioengineering Technology Co., LTD.
·
,
CN
IVD General
CE/IVDD
Igm
Medicon Hellas SA
·
,
GR
Class B
CE/IVDR
Immunoglobulin M (IgM)
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Immunoglobulin M Kit (Turbidimetry Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
Immunoglobin M Kit (Immunoturbidimetric Method)
Medicalsystem Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Immunoglobulin M Assay Kit (Immunoturbidimetric Method)
Da Te Bioengineering Technology Co., LTD.
·
,
CN
IVD General
CE/IVDD
Igm
Medicon Hellas SA
·
,
GR
Class B
CE/IVDR
Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Omlipo IgM Kit
Goldsite Diagnostics Inc.
·
,
CN
IVD General
CE/IVDD
Immunoglobulin M
Thermo Fisher Scientific Oy
·
,
FI
IVD General
CE/IVDR
CE/IVDD
Immunoglobulin M
Diagam S.A.
·
,
BE
IVD General
CE/IVDD
Immunoglobulin M (IgM) Assay Kit (Immunoturbidimetric Method)
Yhlo Biotech (Nanjing) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)
Sansure Biotech Inc.
·
,
CN
IVD General
CE/IVDD
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
Optilite® IgM Kit
The Binding Site Group Ltd
·
,
GB
Class B
FDA 510(k)
K191635
Active
Cleared 15 Jul 2019
CE/IVDR
Immunoglobulin M (IgM) Detection Kit (Nephelometry)
Genrui Biotech Inc.
·
,
CN
IVD General
CE/IVDD
Omlipo IgM Kit
Goldsite Diagnostics Inc.
·
,
CN
IVD General
CE/IVDD
EliA IgM Calibrator Strips
Phadia AB
·
,
SE
Class B
CE/IVDR
GUDID
on market
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