emdn_classification AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Manufacturer:

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd

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eudamed_udi Automatic Elisa Analyzer Manufacturer: Aikang MedTech Co., Ltd

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eudamed_udi AGILITY Manufacturer: Dynex Technologies Inc

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eudamed_udi Automatic Chemiluminescence Immunoassay Analyzer Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.

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eudamed_udi EUROLineCamera Manufacturer: Euroimmun (Hangzhou) Medical Laboratory Diagnostics Co., Ltd

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eudamed_udi Automated Multiplex Immunoassay System Manufacturer: Chengdu Illumaxbio Technology Co.,LTD

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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Aikang MedTech Co., Ltd

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eudamed_udi Fluorescence Immunoassay Analyzer Manufacturer: SINGUWAY BIOTECH INC.

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eudamed_udi Chemiluminescent Immunoassay Analyzer Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.

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eudamed_udi Automated Chemiluminescent Immunoassay Analyzing System Manufacturer: Sophonix Co., Ltd.

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eudamed_udi Automated Chemiluminescent Immunoassay Analyzing System Manufacturer: Sophonix Co., Ltd.

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eudamed_udi Automated Chemiluminescent Immunoassay Analyzing System Manufacturer: Sophonix Co., Ltd.

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eudamed_udi Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90 Manufacturer: Suzhou Astrabio Technology Co., Ltd.

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eudamed_udi NOVEOS X Automatic Chemiluminescence Immunoassay Analyzer Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd

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eudamed_udi Automated Chemiluminescent Immunoassay Analyzing System Manufacturer: Sophonix Co., Ltd.

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eudamed_udi Automated Electrochemiluminescence (ECL) Immunoassay Analyzer Manufacturer: Accucise Diagnostics Inc.

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eudamed_udi Aptiva® Multi-Analyte Instrument Manufacturer: Inova Diagnostics. Inc.

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eudamed_udi COPROSS Manufacturer: NEOMEDICA DOO NIŠ

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd

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eudamed_udi cobas e 411 analyzer (disk system) Manufacturer: Hitachi High-Tech Corporation

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eudamed_udi Chemiluminescence Analyzer Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.

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eudamed_udi Automated CLEIA system Manufacturer: Chengdu Illumaxbio Technology Co.,LTD

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eudamed_udi ABSOL Manufacturer: Absology Co., Ltd.

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eudamed_udi Fully Automatic Immunohistochemistry Stainer Manufacturer: Henan Celnovte Biotechnology Co., Ltd.

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eudamed_udi B·R·A·H·M·S KRYPTOR compact PLUS Manufacturer: B·R·A·H·M·S GmbH

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eudamed_udi Automated Multiplex Immunoassay System Manufacturer: Chengdu Illumaxbio Technology Co.,LTD

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eudamed_udi KROMA Plus iT Automatic Immunological Analyzer Manufacturer: Linear Chemicals S.L.U

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eudamed_udi Smarlumi™ Automatic Chemiluminescence Immunoassay Analyzer Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.

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eudamed_udi Automatic Chemiluminescence Immunoassay Analyzer Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.

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eudamed_udi Fluorescence Immunoassay Analyzer Manufacturer: Acro Biotech Inc.

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eudamed_udi Automated Chemiluminescence Immunoassay Analyzer Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

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eudamed_udi Feces Analysis&Processing System Manufacturer: Hunan Lituo Biotechnology Co., Ltd.

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eudamed_udi RIDA qLine® SysToBlot Manufacturer: R-Biopharm AG

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eudamed_udi Automated Electrochemiluminescence (ECL) Immunoassay Analyzer Manufacturer: Accucise Diagnostics Inc.

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eudamed_udi S-Blot 3 Manufacturer: Sugentech, Inc.

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd

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eudamed_udi Automated CLEIA system Manufacturer: Chengdu Illumaxbio Technology Co.,LTD

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eudamed_udi BlueScan/DrDot Software Manufacturer: D-tek s.a.

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eudamed_udi Fluorescence Immune Analyzer Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.

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eudamed_udi BluBox Manufacturer: Blusense Diagnostics ApS

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eudamed_udi Fluorescence Immunoassay Analyzer Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd

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eudamed_udi DS2 Automated ELISA System Manufacturer: Dynex Technologies Inc

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eudamed_udi Automatic Chemiluminescence Immunoassay Analyzer Manufacturer: Keylights Biotechnology (Chongqing) Co.,Ltd.

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eudamed_udi QMIA Manufacturer: QuantaMatrix Inc.

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eudamed_udi Quantum Dot Fluorescence Immune Analyzer Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.

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eudamed_udi Dräger DrugTest 5000 Analyzer Manufacturer: Dräger Safety AG & Co. KGaA

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eudamed_udi BlueDiver Instrument I Manufacturer: D-tek s.a.

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eudamed_udi AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 Manufacturer: Tosoh Corporation

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eudamed_udi Automated Chemiluminescence Analyzer Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.

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eudamed_udi Agnitio BioIC Analyzer Manufacturer: AGNITIO SCIENCE &TECHNOLOGY,INC.

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd

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eudamed_udi cobas e 411 analyzer (rack system) Manufacturer: Hitachi High-Tech Corporation

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eudamed_udi Microfluidic immunoassay analyzer Manufacturer: Yantai JIEZI Biotechnology Co., Ltd.

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd

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eudamed_udi DSX Automated ELISA System Manufacturer: Dynex Technologies Inc

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eudamed_udi JUNO Automatic eCLIA Analyzer Manufacturer: Linear Chemicals S.L.U

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eudamed_udi Automatic Elisa Analyzer Manufacturer: Aikang MedTech Co., Ltd

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eudamed_udi BlueDiver Instrument II Manufacturer: D-tek s.a.

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eudamed_udi DS2 Automated ELISA System Manufacturer: Dynex Technologies Inc

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eudamed_udi BlueDiver Instrument I Manufacturer: D-tek s.a.

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eudamed_udi HAILSTORM Manufacturer: Gold Standard Diagnostics, LLC

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eudamed_udi Specific Protein Analyzer Manufacturer: Genrui Biotech Inc.

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd

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eudamed_udi Automatic Chemiluminescence Immunoassay Analyzer Manufacturer: Keylights Biotechnology (Chongqing) Co.,Ltd.

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eudamed_udi Automated Immunoassay System HISCL-800 Manufacturer: SYSMEX CORPORATION

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eudamed_udi Smarlumi™ Automatic Chemiluminescence Immunoassay Analyzer Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.

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eudamed_udi Automated Flow Fluorescence Immunoassay Analyzer Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd

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eudamed_udi Automatic Specific Proteins Analyzer Manufacturer: Maccura Medical Instrument Co., Ltd.

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eudamed_udi AGILITY Manufacturer: Dynex Technologies Inc

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eudamed_udi EXENT® Analyser Manufacturer: The Binding Site Group Ltd

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eudamed_udi Fully Automated ELISA Workstation Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.

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eudamed_udi Bolt Manufacturer: Gold Standard Diagnostics, LLC

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eudamed_udi DSX Automated ELISA System Manufacturer: Dynex Technologies Inc

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eudamed_udi LiCA Homogeneous Chemiluminescence System (LiCA System) Manufacturer: Chemclin Diagnostics Co., Ltd.

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eudamed_udi NOVEOS® Immunoassay System Manufacturer: Hycor Biomedical LLC

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eudamed_udi EUROLineMaster II Manufacturer: Euroimmun (Hangzhou) Medical Laboratory Diagnostics Co., Ltd

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eudamed_udi Automated Multiplex Immunoassay System Manufacturer: Chengdu Illumaxbio Technology Co.,LTD

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eudamed_udi Automated Chemiluminescent Immunoassay Analyzing System Manufacturer: Sophonix Co., Ltd.

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eudamed_udi Merilyzer EIAQuant Manufacturer: Meril Diagnostics Pvt. Ltd.

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eudamed_udi Fully Automated Chemiluminescence Immunoassay Analyzer Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd

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eudamed_udi CHORUS EVO Manufacturer: DIESSE Diagnostica Senese S.p.A

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eudamed_udi Chemiluminescence Immunoassay Analyzer Manufacturer: Xiamen Boson Biotech Co., Ltd.

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eudamed_udi ImmuView® Reader 2.0 Manufacturer: SSI Diagnostica A/S

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eudamed_udi Gemini Compact Microplate Processor Manufacturer: STRATEC SE

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eudamed_udi BlueScan/DrDot Software Manufacturer: D-tek s.a.

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eudamed_udi ThunderBolt EIA (CLIA) Manufacturer: Gold Standard Diagnostics, LLC

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eudamed_udi AGILITY Manufacturer: Dynex Technologies Inc

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eudamed_udi Automated CLEIA system Manufacturer: Chengdu Illumaxbio Technology Co.,LTD

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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: Hunan Drawray Biotech Co., Ltd.

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eudamed_udi Phadia Instruments Manufacturer: Phadia AB

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eudamed_udi MAX 45k Manufacturer: MacroArray Diagnostics

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eudamed_udi DxC 500i Clinical Analyzer Manufacturer: Beckman Coulter Inc.

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eudamed_udi DSX Automated ELISA System Manufacturer: Dynex Technologies Inc

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eudamed_udi Agnitio BioIC Analyzer Manufacturer: AGNITIO SCIENCE &TECHNOLOGY,INC.

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FDA Product Code: W0201020101