BEUDAMED
    Product Code: JMT FDA class 1 21 CFR 862.1510

    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

    Clinical Chemistry

    This device is a colorimetric clinical chemistry reagent system using the diazo reaction to qualitatively detect nitrite in urine on a non-quantitative basis, used as part of urinalysis test strips or reagent panels to screen for urinary tract infections caused by nitrite-producing bacteria. It is classified as FDA Class 1, subject only to general controls with no premarket submission required. The product code is JMT, regulated under 21 CFR 862.1510, and assigned to the Clinical Chemistry medical specialty.

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    510(k)s
    13
    FEI Numbers
    79
    Registration Numbers
    79
    Unique Applicants
    12
    Years Active
    42

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    Basic Information

    Product Code
    JMT
    Device Class
    FDA class 1
    Regulation Number
    862.1510
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    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 13 510(k) clearances via K numbers.

    K Number Device Name
    K251800 Healgen® URS Test Strips
    K252607 AllTest Urinary Tract Infection Test
    K242767 Safecare Urinary Tract Infection Test
    K170118 Scanostics UTI Check Application Test System
    K100024 TECO DIAGNOSTICS UTI DETECTION STRIPS
    K993850 URINALYSIS REAGENT STRIPS (10 PARAMETERS)
    K990873 DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
    K954685 URITEST - NITRITE IN URINE TEST
    K960888 CHEK-STIX U.T.I. SELF-TEST
    K953672 FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS
    K875248 BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS
    K855238 BIOTEL (TM)/UTI
    K840828 KYOTEST 8V

    FEI Numbers

    This FDA classification entry is associated with 79 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 79 registration numbers. Click on an entry to view related FDA registrations.