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Product Classification / EMDN Category

FDA Product Code: W0101050205

Directory of devices assigned to product classification code W0101050205.

emdn_classification DIABETES CONTROLS Manufacturer:
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eudamed_udi Seronorm® HbA1c Liquid L-2 Manufacturer: SERO AS
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eudamed_udi OneTouch Verio Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi HbA1c Control Solution Manufacturer: GC MEDIS Corp.
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eudamed_udi Blood Glucose Control Solution Manufacturer: TaiDoc Technology Corporation
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi MAS Diabetes Liquid Assayed Diabetes Control Manufacturer: Microgenics Corporation
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eudamed_udi SimplexTAS HbA1c Control Level 2 Manufacturer: tascom co., ltd.
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi MAS Diabetes Liquid Assayed Diabetes Control Manufacturer: Microgenics Corporation
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eudamed_udi OneTouch Verio Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi Blood Glucose Control Solution Manufacturer: ForaCare Suisse AG
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eudamed_udi ABM-514P Control Solution Manufacturer: All Medicus Co., Ltd.
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eudamed_udi Hemoglobin A1c Kit (Enzymatic Assay Method)、Hemoglobin A1c calibrator、Hemoglobin A1c control Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi Blood Glucose Control Solution Manufacturer: ForaCare Suisse AG
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eudamed_udi AGM-4000 Control Solution Manufacturer: All Medicus Co., Ltd.
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eudamed_udi HbA1c Control Solution Manufacturer: GC MEDIS Corp.
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eudamed_udi ABM-513S Control Solution Manufacturer: All Medicus Co., Ltd.
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Hemoglobin A1c Kit (Enzymatic Assay Method)、Hemoglobin A1c calibrator、Hemoglobin A1c control Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10x2) Manufacturer: sebia
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eudamed_udi ß-Ketone control solution Manufacturer: TaiDoc Technology Corporation
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eudamed_udi ACS018 Manufacturer: ForaCare Suisse AG
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Blood Glucose Control Solution Manufacturer: TaiDoc Technology Corporation
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi HbA1c Control Material Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
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eudamed_udi Seronorm® HbA1c Liquid L-1 Manufacturer: SERO AS
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eudamed_udi AGM-513S Control Solution Manufacturer: All Medicus Co., Ltd.
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eudamed_udi Glycosylated Hemoglobin A1c (HbA1c) Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Hemoglobin A1c Control Set Manufacturer: Tosoh Corporation
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eudamed_udi Glycosylated Hemoglobin A1c (HbA1c) Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi OneTouch Select Plus Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi Blood Glucose Control Solution Manufacturer: ForaCare Suisse AG
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eudamed_udi OneTouch Select Plus Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi GlucoLeader Manufacturer: HMD Biomedical Inc.
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eudamed_udi HbA1c Control Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
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eudamed_udi Hemoglobin A1c Calibrator, Hemoglobin A1c Control Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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eudamed_udi Blood Glucose Control Solution Manufacturer: TaiDoc Technology Corporation
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eudamed_udi OneTouch Verio Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi OneTouch Select Plus Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi OneTouch Verio Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi ABM-513S Control Solution Manufacturer: All Medicus Co., Ltd.
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eudamed_udi HEMOGLOBIN A1C CONTROL (ELEVATED) Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi spinit® HbA1c control Manufacturer: biosurfit SA
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eudamed_udi HbA1c Manufacturer: Instrumentation Laboratory SpA
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eudamed_udi HbA1c Control Turbitest AA Manufacturer: Wiener Laboratorios SAIC
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eudamed_udi FIHBA-PN20 Manufacturer: Healgen Scientific Limited Liability Company
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eudamed_udi Glucose Control Solution Manufacturer: GC MEDIS Corp.
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eudamed_udi MAS Diabetes Liquid Assayed Diabetes Control Manufacturer: Microgenics Corporation
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eudamed_udi extendSURE™ HbA1c Liquid Controls Manufacturer: Canterbury Scientific Limited
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eudamed_udi GLUCOHEMOGLOBINA AUTOMATICA (HbA1c), KIT CONTROLES Manufacturer: QUIMICA CLINICA APLICADA S.A.
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eudamed_udi OneTouch Select Plus Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi GLUCOHEMOGLOBINA (HbA1), JUEGO DE CONTROLES Manufacturer: QUIMICA CLINICA APLICADA S.A.
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eudamed_udi C-peptide Control Solution (FIA) Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
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eudamed_udi Glycohemoglobin Quality Control Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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eudamed_udi ABM-514P Control Solution Manufacturer: All Medicus Co., Ltd.
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi HBA1C CONTROL SET Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
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eudamed_udi Glycohemoglobin Quality Control Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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eudamed_udi HEMOGLOBIN A1C CONTROL (NORMAL) Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi A1c Go HbA1c Control Manufacturer: Goldsite Diagnostics Inc.
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eudamed_udi Glycosylated Hemoglobin A1c (HbA1c) Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi AGM-513S Control Solution Manufacturer: All Medicus Co., Ltd.
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eudamed_udi HbA1c Control Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
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eudamed_udi AGM-2200 Control Solution Manufacturer: All Medicus Co., Ltd.
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eudamed_udi AGM-4000 Control Solution Manufacturer: All Medicus Co., Ltd.
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eudamed_udi HbA1c DIRECT CONTROLS Manufacturer: PZ CORMAY Spółka Akcyjna
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eudamed_udi Blood Glucose Control Solutions Manufacturer: YASEE BioMedical Inc.
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eudamed_udi Agamatrix Control Solution Normal Manufacturer: AgaMatrix, Inc.
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eudamed_udi OneTouch Ultra Plus Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi CERA-CHEK™ 1070 Glucose Control Solution Manufacturer: GC MEDIS Corp.
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eudamed_udi HbA1c Control Material Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
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eudamed_udi Blood Glucose Control Solution Manufacturer: TaiDoc Technology Corporation
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eudamed_udi NOVA Lite® IFA Pancreatic Islet Cell Positive Control Manufacturer: Inova Diagnostics. Inc.
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eudamed_udi OneTouch Verio Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi extendSURETM Haemoglobin A1c Lyophilised Controls Manufacturer: Canterbury Scientific Limited
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eudamed_udi OneTouch Verio Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi Blood Glucose Control Solution Manufacturer: Bionime Corporation
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi HbA1c Control Manufacturer: Cypress Diagnostics
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi CERA-STAT™ HbA1c Control Solution Manufacturer: GC MEDIS Corp.
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eudamed_udi HbA1c Control Kit Manufacturer: Labnovation Technologies, Inc.
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eudamed_udi ß-Ketone control solution Manufacturer: TaiDoc Technology Corporation
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eudamed_udi Glycosylated Hemoglobin A1c (HbA1c) Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Total Cholesterol control solution Manufacturer: TaiDoc Technology Corporation
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eudamed_udi C-PEPTIDE Manufacturer: Medicon Hellas SA
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eudamed_udi A1c Go HbA1c Control Manufacturer: Goldsite Diagnostics Inc.
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eudamed_udi Hemoglobin A1c Control Set Manufacturer: Tosoh Corporation
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eudamed_udi Blood Glucose Control Solution Manufacturer: ForaCare Suisse AG
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eudamed_udi OneTouch Ultra Plus Control Solution Manufacturer: LifeScan Europe GmbH
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eudamed_udi HbA1c Calibrator Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
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eudamed_udi AGM-2100 Control Solution Manufacturer: All Medicus Co., Ltd.
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eudamed_udi SimplexTAS HbA1c Control Level 1 Manufacturer: tascom co., ltd.
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eudamed_udi Glycated Hemoglobin A1c Control Manufacturer: Maccura Biotechnology Co., Ltd.
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eudamed_udi Blood Glucose Control Solution Manufacturer: TaiDoc Technology Corporation
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eudamed_udi Blood Glucose Control Solutions Manufacturer: EAGLENOS SCIENCES, INC.
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