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    Immunoglobulin E (IgE) ELISA

    FDA UDI
    DRG Instruments Gesellschaft mit beschränkter Haftung·04048474017885·The DRG IgE ELISA is intended for the quantitat...

    Immunoglobulin E (IgE) ELISA

    FDA UDI
    DRG International Inc·00840239017888·The DRG IgE ELISA is intended for the quantitat...

    Total Immunoglobulin E (IgE)

    FDA UDI
    Beckman Coulter, Inc.·15099590701727·Total Immunoglobulin E (IgE) Reagent kit for AU...

    Total Immunoglobulin E (IgE)

    FDA 510(k)
    FDA Class 2 ·Immunology

    TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    TERUMO SENSIBEAD EIG HCG KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALLERG-E IGE ENZYME IMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    TANDEM-E IGE II CALIBRATION VERIFICATION SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INTRALASE FS LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code HNO·November 5, 2010

    INTRALASE FS1 LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code HNO·November 10, 2010

    IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELECSYS IGE II IMMUNOASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JHR·February 3, 2015

    IMMUNOGLOBULIN E

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JHR·March 29, 2016

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·October 14, 2011

    PLASTIC LIP AND CHEEK SELF-RETAINING RETRACTOR, SELF RETAINING, CHILD SIZE

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code EIG·January 30, 2018

    IMMUNOGLOBULIN E

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JHR·January 26, 2016

    ELECSYS IGE II

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JHR·October 15, 2013

    IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics·May 7, 2014

    IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics·May 7, 2014

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code NKM·April 20, 2020