BEUDAMED
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    CONSULT DIAGNOSTICS HCG DIPSTICK

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·August 15, 2012

    CONSULT DIAGNOSTICS HCG DIPSTICK

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·August 15, 2012

    ELECSYS HE4

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code OIU·July 12, 2024

    ELECSYS HE4 ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code OIU·July 9, 2025

    ALINITY I HE4 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code OIU·July 1, 2022

    ARCHITECT HE4

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code OIU·January 14, 2019

    ELECSYS HE4

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code OIU·December 20, 2023

    ELECSYS HE4

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code OIU·March 18, 2026

    ARCHITECT HE4 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code OIU·February 6, 2026

    ARCHITECT HE4

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code OIU·June 9, 2016

    ARCHITECT HE4

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code OIU·June 24, 2015

    ELECSYS HE4 ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code OIU·January 18, 2022

    ION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 20, 2012

    ION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 20, 2012

    Test, Epithelial Ovarian Tumor Associated Antigen (He4)

    FDA classification
    FDA Class 2 ·Test, Epithelial Ovarian Tumor Associated Antigen (He4)

    OTU Medical Inc

    FDA registration
    OTU Medical Inc·4 products·🇺🇸 United States

    OUI LAB INC.

    FDA registration
    OUI LAB INC.·11 products·🇺🇸 United States

    Gro3X DIU

    FDA UDI
    Gro3x, Inc.·00860006572501·Gro3X DIU system is an optical impression syste...

    EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.

    FDA Recall
    Terminated ·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHR·May 10, 2019

    GALACTOGRAPHY INFUSION, 30 GA

    FDA UDI
    RANFAC CORP.·M9796800805M0·GALACTOGRAPHY INFUSION, 30 GA GIU-30