501 results
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9ms
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Sources: EU EUDAMED, US FDA
ALK/ROS1/RET Gene Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·1 device
Thyroid carcinoma RET Gene Fusions Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·1 device
Diagnostic Kit for Calprotectin（Fluorescence Immunochromatographic Assay）
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·1 device
SARS-CoV-2 Antigen Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·1 device
SARS-CoV-2/Influenza A/Influenza B Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·1 device
Influenza A/B Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·1 device
IL-6 Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
BNP Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
25-OH-Vitamin D Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Vitamin B12 Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Sialic Acid (SA) Kit (Enzymatic Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Serum Amyloid A (SAA) Kit (Latex Enhanced Immunoturbidimetric Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Glutathione Reductase (GR) Kit (Rate Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Myoglobin (MYO) Kit (Latex Enhanced Immunoturbidimetric Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Lipase (LPS) Kit (Colorimetric Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Magnesium (Mg) Kit (Xylidyl Blue Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Total Protein (TP) Kit (Biuret Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
High Density Lipoprotein Cholesterol (HDL-C) Kit (Enzymatic Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Direct Bilirubin (DBIL) Kit (Vanadate Oxidation Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Total Bilirubin (TBIL) Kit (Vanadate Oxidation Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device