BEUDAMED
    Product Code: NGL FDA class 2 21 CFR 862.3650

    Test, Opiates, Over The Counter

    Clinical Toxicology

    The Test, Opiates, Over The Counter (product code NGL) is an in vitro diagnostic test for consumer home use that detects opiate analytes in urine specimens, used for screening for opiate use or misuse. It is classified as an FDA Class 2 device within the Clinical Toxicology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    23
    FEI Numbers
    57
    Registration Numbers
    57
    Unique Applicants
    16
    Years Active
    17

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    Basic Information

    Product Code
    NGL
    Device Class
    FDA class 2
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    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 23 510(k) clearances via K numbers.

    K Number Device Name
    K253567 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
    K250803 Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
    K250067 Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
    K242428 Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
    K243365 Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
    K243064 ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
    K242802 CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
    K241869 BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader
    K241969 Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel
    K241741 SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel
    K241100 Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
    K240949 Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)
    K240686 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
    K240654 SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette
    K240295 InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)
    K234006 AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
    K240351 FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
    K233417 AllTest Fentanyl Urine Test Cassette
    K193480 BIOEASY Multi-Drug Test Cup
    K190412 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
    K181790 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
    K100108 AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
    K082898 AMEDICA DRUG SCREEN TEST CUP

    FEI Numbers

    This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.