1,090 results · 9ms · Sources: EU EUDAMED, US FDA

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Fer Test Kit (Fluorescence Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device

Automatic Hematology Analyzer F-DR Diluent

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EU IVDR · Eu Ivd Class A ·Maccura Biotechnology Co., Ltd. ·1 device

Ferritin (FER) Chemiluminescence Quantitative Immunoassay Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Beijing Leadman Biochemistry Co., Ltd.·1 device

Automatic Hematology Analyzer F-FR Fluorescent Dye

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EU IVDR · Eu Ivd Class A ·Maccura Biotechnology Co., Ltd. ·1 device

Ferritin (Fer) Kit (Latex Enhanced Immunoturbidimetric Transmission Method)

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EU IVDD · Eu Ivd General ·Zybio Inc.·1 device

Ferritin Kit (Particle-enhanced Immunoturbidimetric Assay Method)、FER Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices

Cancer Antigen 125(CLIA)、CA125 Calibrators

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EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

PT/INR test strip

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EU IVDD · Eu Ivd Self Testing ·Helixgen (GUANGZHOU) Co., Ltd.·1 device

ISE Quality Control Material

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EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·1 device

Assay Kit for Electrolytes Analysers (Ion-selective Electrode Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·3 devices

Multiple compound quality control products for biochemical immunity

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EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·4 devices

Multiple biochemical calibrators

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EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·2 devices

Full Range C-Reactive Protein Test Kit (Latex-Enhanced Immunoturbidimetric Assay)

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EU IVDR · Eu Ivd Class C ·URIT Medical Electronic Co.,Ltd.·5 devices

α-Amylase Reagent Kit(EPS Substrate Method)

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EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·3 devices

Lactate Dehydrogenase Reagent Kit (Lactic Acid Substrate Method)

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EU IVDR · Eu Ivd Class C ·URIT Medical Electronic Co.,Ltd.·4 devices

Apolipoprotein B (Apo B) Reagent Kit (Immunoturbidimetric Assay)

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EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·6 devices

Apolipoprotein A1 (Apo A1) Assay Kit (Immunoturbidimetric Assay)

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EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·6 devices

Low-density Lipoprotein Cholesterol Reagent Kit (Direct Method-Surfactant Removal Method)

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EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·5 devices

High-density Lipoprotein Cholesterol Reagent Kit (Direct Method-Selected Suppression Method)

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EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·5 devices

Triglycerides Reagent Kit (Enzymatic Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·5 devices