BEUDAMED
    Product Code: MSQ FDA class 1 21 CFR 866.3110

    Test, Urea (Breath Or Blood)

    Microbiology

    A Urea Breath or Blood Test is a diagnostic device used to detect the presence of Helicobacter pylori infection in the stomach by measuring labeled carbon dioxide exhaled after ingesting labeled urea, or by measuring blood-based urea markers, supporting diagnosis and post-treatment assessment. It is classified as FDA Class 1 with product code MSQ, regulated under 21 CFR 866.3110 in the Microbiology specialty. GMP requirements apply and no premarket submission is needed. The device is not an implant and is not life-sustaining.

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    510(k)s
    17
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    9
    Years Active
    25

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    Basic Information

    Product Code
    MSQ
    Device Class
    FDA class 1
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 17 510(k) clearances via K numbers.

    K Number Device Name
    K221896 BreathID Hp System
    K223185 BreathID® Smart System
    K220494 BreathID Hp Lab System, BreathID Smart System
    K193610 BreathID Smart System
    K173777 BreathID Hp Lab System
    K173772 BreathID Hp System
    K162150 BreathID Hp Lab System
    K130524 BREATHID HP SYSTEM
    K093834 CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
    K092817 POC-AS10 AUTO SAMPLER
    K041148 POCONE INFRARED SPECTROPHOTOMETER
    K014225 BREATHTEK - UBIT UBT FOR H. PYLORI
    K011668 VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
    K000316 MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
    K990931 EZ-HBT HELICOBACTER BLOOD TEST
    K973000 ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
    K972352 THE MERETEK UBT BREATH TEST FOR H.PYLORI

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.