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Product Classification / EMDN Category

FDA Product Code: W0102152099

Directory of devices assigned to product classification code W0102152099.

emdn_classification CONTROLS- IMMUNOCHEMISTRY - OTHER Manufacturer:
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eudamed_udi β2-Microglobulin Control Manufacturer: DIRUI INDUSTRIAL CO., LTD
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eudamed_udi Thyroid Function Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi VIC11 Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi Hepatitis A IgG Control Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
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eudamed_udi ImmunoCAP Tryptase Manufacturer: Phadia AB
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eudamed_udi H.Pylori Ag Control Manufacturer: Coei Biotech Co.Ltd.
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eudamed_udi Cholyglycine (Latex Immunoturbidimetric) Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
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eudamed_udi PATHTROL™ ALLERGY CONTROL - LEVEL 2 Manufacturer: Eurobio Scientific UK Ltd
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eudamed_udi NEGATIVE CONTROL Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi FOB multi-level indefinite value controls Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
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eudamed_udi Vigil Serology Control Level 2 Manufacturer: Beckman Coulter Inc.
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eudamed_udi nDNA POSITIVE CONTROL Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi CRP Control 15 Manufacturer: Labquality Oy
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eudamed_udi iPTH Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Hemoglobin Quality Control (Quantitative) Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
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eudamed_udi Thyroid Function Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi PATHTROL™ TRYPTASE HIGH POSITIVE CONTROL Manufacturer: Eurobio Scientific UK Ltd
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eudamed_udi Immunological Multi-Parameter Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Serum Amyloid A (CLIA) Controls Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
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eudamed_udi LIAISON® Control Anti-TPO Manufacturer: DiaSorin Italia S.p.A.
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eudamed_udi Immunological Multi-Parameter Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Thyroid Function Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi D-Dimer Control Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
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eudamed_udi Thyroid Autoantibodies Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi LIAISON® Control Cardiolipin IgG Manufacturer: DiaSorin Italia S.p.A.
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eudamed_udi Beta-2 Microglobulin / Ferritin - Serum / Plasma Control Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
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eudamed_udi IDS-iSYS Cartridge Checking System (CCS) Manufacturer: Immunodiagnostic Systems SA
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eudamed_udi IDS-iSYS Cartridge Checking System (CCS) Manufacturer: Immunodiagnostic Systems SA
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eudamed_udi iPTH Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Access HAV IgM QC Manufacturer: Beckman Coulter Inc.
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eudamed_udi ImmunoCAP ECP Manufacturer: Phadia AB
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eudamed_udi NEGATIVE CONTROL Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi HAV IgM (Liquid) Control Manufacturer: Xiamen Innodx Biotech Co., Ltd.
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eudamed_udi Finecare™ SAA Control Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
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eudamed_udi LKM POSITIVE CONTROL Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi Access HBs Ag QC Manufacturer: Beckman Coulter Inc.
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eudamed_udi ImmunoCAP Specific IgE Manufacturer: Phadia AB
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eudamed_udi Thyroid Function Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi H. pylori Antigen Control Solution (FIA) Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi ImmunoCAP Specific IgE Manufacturer: Phadia AB
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eudamed_udi 1,25-(OH)2-Vitamin D3/D2 ImmuTube® LC-MS/MS Manufacturer: Immundiagnostik AG
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eudamed_udi FOB Quality Control Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
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eudamed_udi IVDR_67_LLB_DUB-C_C_REAG_3gAllergy Spfc IgE Pos Cnt M6 Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
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eudamed_udi Influenza A+B Control Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
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eudamed_udi VALIDATE® aHBs Test Set Manufacturer: LGC Clinical Diagnostics, Inc.
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eudamed_udi Immunological Multi-Parameter Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Thyroid autoantibodies Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi HA Control Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
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eudamed_udi SERUM BONE MARKER CONTROL Manufacturer: Randox Laboratories Limited
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eudamed_udi Thyroid Function Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Immunological Multi-Parameter Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi AMH Control Manufacturer: Fujirebio Diagnostics AB
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eudamed_udi Thyroid Function Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi VIC154 Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi Calprotectin Quality Control (Quantitative) Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
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eudamed_udi Thyroid Function Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Immunochemistry Systems Level 1 Urine Protein Control Manufacturer: Beckman Coulter Inc.
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eudamed_udi Liver Fibrosis (Lyophilized) Control Manufacturer: Xiamen Innodx Biotech Co., Ltd.
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eudamed_udi VivaDiag Procalcitonin Control Solution (FIA) Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi CRP (CLIA) Controls Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
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eudamed_udi CLIA IL-6 Control Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
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eudamed_udi LKM POSITIVE CONTROL Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi Biochemical Quality Control Kit Manufacturer: Hunan Ehome Health Technology Co., Ltd.
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eudamed_udi HbA1c Control Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
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eudamed_udi Access AMH QC Manufacturer: IMMUNOTECH SAS
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eudamed_udi Microalbumin Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi IDS-iSYS Cartridge Checking System (CCS) Manufacturer: Immunodiagnostic Systems SA
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eudamed_udi Respiratory Syncytial Virus Control Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi β2-Microglobulin Calibrator Manufacturer: DIRUI INDUSTRIAL CO., LTD
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eudamed_udi Calprotectin Quality Control (Quantitative) Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
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eudamed_udi nDNA POSITIVE CONTROL Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi SYNCHRON Systems 10 ng/mL THC Urine Control Manufacturer: Beckman Coulter Inc.
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eudamed_udi IDS Total IgE Control Set Manufacturer: Immunodiagnostic Systems Limited
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eudamed_udi Kemilo IL-6 Control Manufacturer: Goldsite Diagnostics Inc.
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eudamed_udi Finecare™ iFOB Control Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
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eudamed_udi IDS-iSYS 1,25 VitDXp Control Set Manufacturer: Immunodiagnostic Systems Limited
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eudamed_udi AESQC® Pool Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi Thyroid Function Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Apo AI/B Control Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
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eudamed_udi Finecare™ PCT Control Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
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eudamed_udi Adenovirus Control Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi ImmunoCAP Specific IgE Manufacturer: Phadia AB
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eudamed_udi AutoLumo analyzer Manufacturer: Autobio Diagnostics Co., Ltd.
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eudamed_udi IDS Positive Specific IgE Control (G006) Timothy Grass Manufacturer: Immunodiagnostic Systems Limited
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eudamed_udi Immunological Multi-Parameter Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Strep A Control Solution (FIA) Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi CRP Control 40 Manufacturer: Labquality Oy
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eudamed_udi Microalbumin Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi Thyroid Function Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Thyroid Function Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Cholylglycine (CLIA) Controls Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
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eudamed_udi IL-6 Control Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
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eudamed_udi Finecare™ IL-6 Control Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
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eudamed_udi VIC83 Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi Immunoglobulin E Control Manufacturer: Spinreact S.A.U.
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eudamed_udi PATHFAST Presepsin Control Manufacturer: PHC Corporation
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eudamed_udi Control IgE SpE - Controllo IgE SpE Manufacturer: ABD SRL
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eudamed_udi Anti-CCP Control Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
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