BEUDAMED
    Product Code: NFT FDA class 2 21 CFR 862.3100

    Test, Amphetamine, Over The Counter

    Clinical Toxicology

    The Test, Amphetamine, Over The Counter (product code NFT) is an in vitro diagnostic test designed for consumer home use to detect the presence of amphetamines in urine specimens, intended for drug screening without professional laboratory involvement. 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
    30
    FEI Numbers
    49
    Registration Numbers
    49
    Unique Applicants
    14
    Years Active
    9

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    Basic Information

    Product Code
    NFT
    Device Class
    FDA class 2
    Regulation Number
    862.3100
    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 30 510(k) clearances via K numbers.

    K Number Device Name
    K261280 BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
    K260065 SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
    K260355 Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
    K252550 SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
    K252867 VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
    K252554 Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
    K252118 CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
    K252259 AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
    K250727 AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
    K244043 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
    K243996 AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
    K242498 Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC
    K242540 AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel
    K242077 PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
    K241428 AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
    K233062 BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
    K222667 Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
    K221871 Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
    K220685 HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
    K202453 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
    K202567 Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
    K201120 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
    K191841 Accurate Multi Panel Drug Urine Test Cup
    K182701 Wondfo T-Cup Multi-Drug Urine Test Cup
    K182530 BIOEASY Multi-Drug Test Cup
    K181968 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
    K181768 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
    K180349 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
    K171695 First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana
    K170049 AssureTech Panel Dip Test, AssureTech Quick Cup Test

    FEI Numbers

    This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.