BEUDAMED
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    Cala kIQ

    FDA UDI
    CALA HEALTH, INC.·00851749007450·Cala kIQ Band, Large

    Cala kIQ

    FDA UDI
    CALA HEALTH, INC.·00851749007412·Stimulator

    Cala kIQ

    FDA UDI
    CALA HEALTH, INC.·00851749007474·Cala kIQ Band, Large

    Cala kIQ

    FDA UDI
    CALA HEALTH, INC.·00851749007429·Base Station

    Cala kIQ

    FDA UDI
    CALA HEALTH, INC.·00851749007498·Cala kIQ Band, Small

    Cala kIQ

    FDA UDI
    CALA HEALTH, INC.·00851749007481·Cala kIQ Band, Medium

    Cala kIQ

    FDA UDI
    CALA HEALTH, INC.·00851749007436·Cala kIQ Band, Small

    Cala kIQ

    FDA UDI
    CALA HEALTH, INC.·00851749007443·Cala kIQ Band, Medium

    Cala kIQ

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cala kIQ

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cala kIQ

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cala kIQ Plus

    FDA 510(k)
    FDA Class 2 ·Neurology

    CALA KIQ

    FDA Adverse Event
    Injury ·CALA HEALTH INC·Product code QBC·June 18, 2025

    CALA KIQ

    FDA Adverse Event
    Injury ·CALA HEALTH INC·Product code QBC·April 1, 2026

    CALA KIQ

    FDA Adverse Event
    Injury ·CALA HEALTH·Product code QBC·December 23, 2024

    ANORA COLLECTION KIT

    FDA Adverse Event
    Malfunction ·NATERA·Product code KIQ·January 19, 2018

    ANORA

    FDA Adverse Event
    Malfunction ·NATERA·Product code KIQ·January 30, 2018

    Kit, Culture, Chromosome

    FDA classification
    FDA Class 1 ·Kit, Culture, Chromosome

    AIQ SOLUTIONS

    FDA registration
    AIQ SOLUTIONS·2 products·🇺🇸 United States

    iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·May 24, 2023