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Product Classification / EMDN Category

FDA Product Code: W0201069099

Directory of devices assigned to product classification code W0201069099.

emdn_classification VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER Manufacturer:
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eudamed_udi Lipid Analyzer Manufacturer: Newlink Biotech co., Ltd.
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eudamed_udi STANDARD™ F200 Analyzer Manufacturer: SD Biosensor Inc.
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eudamed_udi Handheld DOA Reader Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
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eudamed_udi Hemoglobin Test Meter Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
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eudamed_udi Dry Fluorescence Immunoassay Analyzer Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
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eudamed_udi Blood glucose, uric acid, and total cholesterol multi-monitoring system Manufacturer: General Life Biotechnology Co., Ltd.
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eudamed_udi RAPID TEST READER Manufacturer: KAIWOOD Technology Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
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eudamed_udi Immunofluorescence Analyzer Manufacturer: Vitrosens Biotechnology Inc.
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eudamed_udi Qassay Lateral Flow Reader DUAL Manufacturer: P4Q Health S.L.U.
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eudamed_udi SmartTester Manufacturer: 77 Elektronika Műszeripari Kft
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eudamed_udi Compass2800-1, Compass2800-2 Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
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eudamed_udi Uric acid monitoring system Manufacturer: General Life Biotechnology Co., Ltd.
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eudamed_udi Fluorescence Immunoassay Analyzer Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
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eudamed_udi Blood Glucose / Blood Ketone / Uric Acid/ Hemoglobin Multi-Monitoring system Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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eudamed_udi Compass2800-1, Compass2800-2 Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
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eudamed_udi Colloidal gold immunochromatography reader Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
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eudamed_udi Lipid Analyzer Manufacturer: Newlink Biotech co., Ltd.
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eudamed_udi Multi-Channel Immunoflourescence Analyzer Manufacturer: Vitrosens Biotechnology Inc.
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eudamed_udi Glucose/Ketone/Uric Acid/Total Cholesterol Meter Pro Manufacturer: Aceso Laboratories, Inc.
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eudamed_udi Multi-channel Immunofluorescence Analyzer Manufacturer: Healgen Life Science LLC
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eudamed_udi Blood glucose, uric acid, and total cholesterol multi-monitoring system Manufacturer: General Life Biotechnology Co., Ltd.
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eudamed_udi Fluorescence Immunoassay Analyzer Manufacturer: Xiamen Boson Biotech Co., Ltd.
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eudamed_udi Colloidal gold immunochromatography reader Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
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eudamed_udi PATHFAST Manufacturer: PHC Corporation
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eudamed_udi OG-H180 Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
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eudamed_udi STANDARD™ F200 Analyzer Manufacturer: SD Biosensor Inc.
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eudamed_udi Multi Function Immunofluorescence Analyzer Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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eudamed_udi Curian Analyzer Manufacturer: Meridian Bioscience Inc.
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eudamed_udi Blood glucose, uric acid, and total cholesterol multi-monitoring system Manufacturer: General Life Biotechnology Co., Ltd.
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eudamed_udi OG-G260 Manufacturer: Healgen Scientific Limited Liability Company
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eudamed_udi Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system Ⅰ Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
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eudamed_udi Handheld DOA Reader Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
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eudamed_udi Renal Function Test Strip Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
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eudamed_udi Ep.414 Manufacturer: DxGen Corp.
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eudamed_udi Semi-Automatic Fluorescence Immunassay Analyzer Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
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eudamed_udi FLI-600 FIA Analyzer Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
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eudamed_udi Multi Function Immunofluorescence Analyzer Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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eudamed_udi STANDARD™ F200 Analyzer Manufacturer: SD Biosensor Inc.
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eudamed_udi Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter II Manufacturer: Acro Biotech Inc.
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eudamed_udi Handheld DOA Reader Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
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eudamed_udi Compass2000-1, Compass2000-2 Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
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eudamed_udi TEST KASETİ-1 (62’LİK) Manufacturer: Vitrosens Biotechnology Inc.
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eudamed_udi Dry Fluorescence Immunoassay Analyzer Manufacturer: Coei Biotech Co.Ltd.
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eudamed_udi Multi Function Immunofluorescence Analyzer Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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eudamed_udi Dry Fluorescence Immunoassay Analyzer Manufacturer: Coei Biotech Co.Ltd.
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eudamed_udi STANDARD™ F2400 Analyzer Manufacturer: SD Biosensor Inc.
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eudamed_udi Cholesterol Meter Manufacturer: Acro Biotech Inc.
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eudamed_udi ProciseDx Analyzer Manufacturer: ProciseDx Inc.
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eudamed_udi Blood glucose, uric acid, and total cholesterol multi-monitoring system Manufacturer: General Life Biotechnology Co., Ltd.
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eudamed_udi Dry Biochemistry Immunoassay Analyzer Manufacturer: WWHS Biotech.Inc
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eudamed_udi STANDARD™ F2400 Analyzer Manufacturer: SD Biosensor Inc.
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eudamed_udi STANDARD™ F200 Analyzer Manufacturer: SD Biosensor Inc.
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eudamed_udi Uric Acid Meter Manufacturer: Hangzhou Aokai Biotech Co., Ltd.
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eudamed_udi PATHFAST Manufacturer: PHC Corporation
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eudamed_udi Dry Chemistry Analyzer Manufacturer: Hangzhou Bosure Biotech Co., Ltd
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eudamed_udi Mission Cholesterol Meter Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
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eudamed_udi  Fully Automatic Biochemistry Analyzer Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
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eudamed_udi Afinion 2 Manufacturer: Abbott Diagnostics Technologies AS
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eudamed_udi Blood Glucose and Uric Acid and Total Cholesterol Test Meter Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
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eudamed_udi Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter I Manufacturer: Acro Biotech Inc.
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eudamed_udi Glucose/Ketone/Uric Acid/Total Cholesterol Meter Pro Manufacturer: Aceso Laboratories, Inc.
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eudamed_udi G6PD and Hemoglobin Biosensor Test Meter Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
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eudamed_udi Fluorescence immunoassay (FIA) Analyzer Manufacturer: Diasia Biomedical Technology Co., Ltd.
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eudamed_udi Colloidal gold immunochromatography reader Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
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eudamed_udi GP Reader NT Manufacturer: Biohit Oyj
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eudamed_udi Blood Glucose and β-Ketone Test Meter Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
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eudamed_udi STANDARD™ F2400 Analyzer Manufacturer: SD Biosensor Inc.
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eudamed_udi Multi Function Immunofluorescence Analyzer Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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eudamed_udi Compass3000-1, Compass3000-2 Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
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eudamed_udi OG-G300 Manufacturer: Healgen Scientific Limited Liability Company
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eudamed_udi Fluorescence Immunoassay Analyzer Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
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eudamed_udi i-ImmunDx™ Analyzer Manufacturer: Seinda Biomedical Corporation
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eudamed_udi Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
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eudamed_udi Cholesterol Meter Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
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eudamed_udi Blood glucose, uric acid, and total cholesterol multi-monitoring system Manufacturer: General Life Biotechnology Co., Ltd.
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eudamed_udi Blood Glucose and Uric Acid Meter Manufacturer: Changsha Sinocare Inc.
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eudamed_udi Glucose/Ketone/Uric Acid/Total Cholesterol Meter Manufacturer: Aceso Laboratories, Inc.
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eudamed_udi i-ImmunDx Analyzer Manufacturer: Seinda Biomedical Corporation
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eudamed_udi STANDARD™ F2400 Analyzer Manufacturer: SD Biosensor Inc.
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eudamed_udi Blood glucose, uric acid, and total cholesterol multi-monitoring system Manufacturer: General Life Biotechnology Co., Ltd.
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eudamed_udi Dry Fluorescence Immunoassay Analyzer Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
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eudamed_udi Blood Glucose / Blood Ketone / Uric Acid/ Hemoglobin Multi-Monitoring system Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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eudamed_udi Multi-functional Monitoring Meter Manufacturer: EAGLENOS SCIENCES, INC.
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eudamed_udi OG-H101 Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
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eudamed_udi Hb Hemoglobin Meter Manufacturer: Hangzhou Aokai Biotech Co., Ltd.
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eudamed_udi Cholesterol Meter Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
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eudamed_udi On Call GK Dual Blood Ketone Meter Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
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eudamed_udi Glucose/Ketone/Uric Acid/Total Cholesterol Meter Manufacturer: Aceso Laboratories, Inc.
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eudamed_udi STANDARD™ F2400 Analyzer Manufacturer: SD Biosensor Inc.
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eudamed_udi Immunofluorescence Analyzer Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
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eudamed_udi Portable Incubator Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
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eudamed_udi Uric Acid Meter Manufacturer: Aceso Laboratories, Inc.
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eudamed_udi Colloidal gold immunochromatography reader Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
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eudamed_udi Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter I Manufacturer: Acro Biotech Inc.
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eudamed_udi Blood glucose, uric acid, and total cholesterol multi-monitoring system Manufacturer: General Life Biotechnology Co., Ltd.
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eudamed_udi Blood glucose, uric acid, and total cholesterol multi-monitoring system Manufacturer: General Life Biotechnology Co., Ltd.
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eudamed_udi Cholesterol Meter Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
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eudamed_udi STANDARD™ F2400 Analyzer Manufacturer: SD Biosensor Inc.
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