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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Myoglobin
Myoglobin
W01021304
199 devices
Myoglobin Rapid Test Kit (Fluorescence Immunochromatographic Assay)
Hoyotek Biomedical Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin (MYO) Kit (Particle-enhanced Immunoturbidimetric Assay Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
MYO Assay Kit CLIA
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin Reagent Kit（latex Enhanced Immunoturbidimetric Method）
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Myoglobin (MYO) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA)
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
MYO Assay Kit CLIA
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin Quantitative Diagnostic Kit (CLIA)
Darui Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin assay (CLIA)
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin (MYO) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA)
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Myoglobin STAT (MYO STAT) eCLIA
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
Class C
CE/IVDR
MyoCheck Myo Quantitativer Schnelltest (Fluoreszenz Immunoassay)
Xiamen Biotime Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin Kit (CLIA)
Medicalsystem Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin Rapid Test Kit (Fluorescence Immunochromatographic Assay)
Hoyotek Biomedical Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin(MyO)Detection Kit(CLIA)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Access Myoglobin
Beckman Coulter, Inc.
·
,
United States
Class B
FDA 510(k)
K231832
Active
Cleared 18 Sep 2023
CE/IVDR
+1
authorizations
Myoglobin Assay Kit (Immunochromatographic Assay)
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin(MYO) Assay Kit(Chemiluminescent Immunoassay)
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myo (Clia)
Medcaptain Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Myoglobin (Myo) Assay Kits (Lateral Flow Immunoassay)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin (MB) Test Kit (Immunoturbidimetric)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
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