BEUDAMED
    1,012 results · 33ms · Sources: EU EUDAMED, US FDA

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    TDXFLX SYSTEM

    FDA Adverse Event
    Other ·ABBOTT MFG., INC.·Product code LCQ·September 11, 1998

    TDXFLX SYSTEM

    FDA Adverse Event
    Other ·ABBOTT MANUFACTURING, INC.·Product code LCQ·September 11, 1998

    TDX/TDXFLX GENTAMICIN REAGENT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code LCQ·November 8, 2007

    TDXFLX SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code LCQ·August 24, 2007

    TDX FPIA ANALYZER

    FDA Adverse Event
    Other ·ABBOTT MANUFACTURING, INC·Product code LCQ·August 30, 2007

    AXSYM GENTAMICIN

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code LCQ·April 30, 2008

    TDX/TDXFLX GENTAMICIN REAGENT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code LCQ·January 4, 2008

    Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DKB·August 11, 2009

    Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DLZ·August 11, 2009

    Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007

    Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code LCQ·November 11, 2015

    Fluorescent Immunoassay Gentamicin

    FDA classification
    FDA Class 2 ·Fluorescent Immunoassay Gentamicin

    Clear Capture, LCC

    FDA registration
    Clear Capture, LCC·1 product·🇺🇸 United States

    GAMMA CLQ

    FDA 510(k)
    FDA Class 2 ·Immunology

    DAU LC 1

    FDA UDI
    UTAK LABORATORIES, INC.·B800507020·DAU LC 1

    DAU LC 2

    FDA UDI
    UTAK LABORATORIES, INC.·B800507030·DAU LC 2

    LCR Hallcrest, LLC. (IL)

    FDA registration
    LCR Hallcrest, LLC. (IL)·5 products·🇺🇸 United States

    YEASN

    FDA UDI
    Chongqing Yeasn Science & Technology Co.,Ltd.·06971922131674·

    YEASN

    FDA UDI
    Chongqing Yeasn Science & Technology Co.,Ltd.·06971922131292·