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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Individual and specific hormones / proteins
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Renal metabolism assays
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Renal metabolism tests - other
Renal metabolism tests - other
W0102060299
7 devices
Devices
Kidney Injury Molecule 1 Rapid Test Kit (FIA)
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
CN
IVD General
CE/IVDD
Vidas® Nephrocheck®
Biomerieux SA
·
,
FR
Class B
FDA 510(k)
K210793
Active
Cleared 8 Jul 2022
CE/IVDR
Adrendcorticotrophic Hormone(ACTH)Detection Kit(CLIA)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
CN
IVD General
CE/IVDD
Vidas® Nephrocheck®
Biomerieux SA
·
,
FR
Class B
CE/IVDR
mAlb Test Kit (Dry Fluorescence Immunoassay)
Lansion Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Microalbuminuria Determination Kit（Fluorescence Immunochromatographic Assay）
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
CN
Class B
CE/IVDR
ACTH Adrenocorticotropic Hormone (CLIA)
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
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