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Product Classification / EMDN Category

FDA Product Code: W0201020102

Directory of devices assigned to product classification code W0201020102.

emdn_classification AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Manufacturer:
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eudamed_udi KleeYa® Instrument Manufacturer: STRATEC SE
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eudamed_udi IDS-iSYS Multi-Discipline Automated System Manufacturer: ImmunoDiagnostic Systems France
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eudamed_udi Automatic Luminescence Immunoassay Analyzer Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
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eudamed_udi OC Equipment Family Manufacturer: EIKEN CHEMICAL CO., LTD.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Taizhou Zecen Biotech Co., Ltd.
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eudamed_udi HOKAPI™ AE-200 Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
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eudamed_udi Automatic Electrochemiluminescence Immunoassay Analyzer Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400 Manufacturer: Tosoh Corporation
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Increcare Biotech Co., Ltd
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eudamed_udi MAGLUMI 800 Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
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eudamed_udi QUANTA-Lyser® 3000 ELISA/IFA Manufacturer: Inova Diagnostics. Inc.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: URIT Medical Electronic Co.,Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Increcare Biotech Co., Ltd
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Zybio Inc.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Increcare Biotech Co., Ltd
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Taizhou Zecen Biotech Co., Ltd.
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eudamed_udi Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
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eudamed_udi Portable FIA Analyzer Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
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eudamed_udi IVDR_67_TTN_DUB-C_A_INST_1300 Analyzer Manufacturer: Siemens Healthcare Diagnostics Inc.
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eudamed_udi Chemiluminescence Analyzer Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Zybio Inc.
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eudamed_udi Automated ECLImmunoassay Analyzer Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
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eudamed_udi Automatic Luminescence Immunoassay Analyzer Manufacturer: Autobio Labtec Instruments Co.,Ltd.
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eudamed_udi Fully automatic chemiluminescence immunoassay analyzer Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
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eudamed_udi Fully Automated Fecal Immunochemical Test Analyzer Manufacturer: Shenzhen Cavan Biotech Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Increcare Biotech Co., Ltd
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eudamed_udi POCT Analyzer Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi Automatic Chemiluminescence Analyzer Manufacturer: Maccura Medical Instrument Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Increcare Biotech Co., Ltd
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eudamed_udi AP IFA-BLOT Manufacturer: DAS Srl
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eudamed_udi IDS-iSYS Multi-Discipline Automated System Manufacturer: ImmunoDiagnostic Systems France
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eudamed_udi IMMAGE 800 Manufacturer: Beckman Coulter Inc.
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eudamed_udi POCT Analyzer VIM2000 Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi AP ELISA-IFA Manufacturer: DAS Srl
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi Fully-auto Specific Protein Analyzer Manufacturer: Genrui Biotech Inc.
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eudamed_udi Fluorescence Immunoassay Analyzer Manufacturer: BIOBASE POCT CO.,LTD
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eudamed_udi AP ELISA-IFA-BLOT Manufacturer: DAS Srl
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eudamed_udi LiCA Homogeneous Chemiluminescence System (LiCA System) Manufacturer: Chemclin Diagnostics Co., Ltd.
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eudamed_udi Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
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eudamed_udi AP ELISA Manufacturer: DAS Srl
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eudamed_udi QUANTA-Lyser® 3000 IFA Manufacturer: Inova Diagnostics. Inc.
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eudamed_udi cobas e 402 analytical unit Manufacturer: Hitachi High-Tech Corporation
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eudamed_udi Automated Chemiluminescence Immunoassay Analyzer Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
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eudamed_udi Hematology Analysis Automation Workstation Manufacturer: Maccura Medical Instrument Co., Ltd.
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eudamed_udi Chemiluminescence Analyzer Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
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eudamed_udi IDS-i10 Manufacturer: Immunodiagnostic Systems Limited
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eudamed_udi STANDARD™ i Wash buffer Manufacturer: SD Biosensor Inc.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Xiamen Boson Biotech Co., Ltd.
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eudamed_udi Automatic Chemiluminescence Immunoassay Analyzer Manufacturer: Wuhan BGI Biomedical Engineering Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Taizhou Zecen Biotech Co., Ltd.
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eudamed_udi AP IFA Manufacturer: DAS Srl
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eudamed_udi Chemiluminescence Analyzer Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
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eudamed_udi Fluorescence Immunoassay Analyzer Manufacturer: BIOBASE POCT CO.,LTD
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eudamed_udi DIA500 Manufacturer: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Zybio Inc.
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eudamed_udi Aucheer iMAGIN 1800 Chemiluminescence Immunoassay Analyzer Manufacturer: NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.
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eudamed_udi Automatic Luminescence Immunoassay Analyzer Manufacturer: Autobio Labtec Instruments Co.,Ltd.
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eudamed_udi STANDARD™ i1000 Manufacturer: SD Biosensor Inc.
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eudamed_udi IVDR_67_TTN_DUB-C_A_INST_1300 Analyzer Manufacturer: Siemens Healthcare Diagnostics Inc.
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eudamed_udi Auto Chemiluminescence Analyzer Manufacturer: Genrui Biotech Inc.
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eudamed_udi Automatic Chemiluminescence lmmunoanalyzer Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
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eudamed_udi Automatic Electrochemiluminescence Immunoassay Analyzer Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: DIRUI INDUSTRIAL CO., LTD
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eudamed_udi Automatic Luminescence Immunoassay Analyzer Manufacturer: Autobio Labtec Instruments Co.,Ltd.
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eudamed_udi Fully automatic chemiluminescence immunoassay analyzer Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
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eudamed_udi POCT Analyzer Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
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eudamed_udi Automated Chemiluminescence Immunoassay Analyzer Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
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eudamed_udi STANDARD™ i2000 Manufacturer: SD Biosensor Inc.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi Optilite® Analyser Manufacturer: The Binding Site Group Ltd
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eudamed_udi Personal LAB Manufacturer: ADALTIS SRL
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eudamed_udi AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 Manufacturer: Tosoh Corporation
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eudamed_udi HOKAPI™ AE-180 Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
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eudamed_udi Automated ECLImmunoassay Analyzer Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi Automated Chemiluminescence Immunoassay Analyzer Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
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eudamed_udi Fully Automated Fecal Immunochemical Test Analyzer Manufacturer: Shenzhen Cavan Biotech Co., Ltd.
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eudamed_udi Portable Immune Analyzer Manufacturer: Xiamen Wiz Biotech Co., Ltd.
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eudamed_udi AL1200 analyzer 120 Manufacturer: Technogenetics S.p.A
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eudamed_udi GBC Chemiluminescence Analyzer (Non-Sterile) Manufacturer: General Biologicals Corporation
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eudamed_udi Automatic Chemiluminescence Immunoassay Analyzer Manufacturer: Wuhan BGI Biomedical Engineering Co., Ltd.
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eudamed_udi Fully Automated Fecal Immunochemical Test Analyzer Manufacturer: Shenzhen Cavan Biotech Co., Ltd.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Zybio Inc.
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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Increcare Biotech Co., Ltd
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eudamed_udi AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 Manufacturer: Tosoh Corporation
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eudamed_udi Eu-Turbo Analyzer Manufacturer: Eurospital Spa
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eudamed_udi Automated Chemiluminescence Immunoassay Analyzer Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
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eudamed_udi Chemistry Analyzer Manufacturer: Zybio Inc.
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eudamed_udi Automatic Chemiluminescence Analyzer Manufacturer: Maccura Medical Instrument Co., Ltd.
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eudamed_udi Fully Auto Chemiluminescence Analyzer Manufacturer: Nanjing RealMind Biotech Co., Ltd.
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