Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K152643
    Device Name
    EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
    Manufacturer
    NANTONG EGENS BIOTECH CO., LTD.
    Date Cleared
    2015-11-02

    (48 days)

    Product Code
    LDJ, LAF
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    NANTONG EGENS BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EGENS Urine Test Cup THC-MDMA is a rapid test for the qualitative detection of Cannabinoids and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 50 ng/mL respectively. EGENS Urine Test Cup THC-MDMA test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. CCMS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. EGENS Urine Test DipCard THC-MDMA is a rapid test for the qualitative detection of Cannabinoids and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 50 ng/mL and 500 ng/mL, respectively. EGENS Urine Test DipCard THC-MDMA test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. EGENS Urine Test Cassette Marijuana is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL. EGENS Urine Test Cassette Marijuana test provides only preliminary test results. A more specific alternative chemial method must be used in order to obtain a confirmed analytical result. CC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
    Device Description
    EGENS Urine Test MDMA uses immunochromatographic assays for Methylenedioxymethamphetamine. These tests are lateral flow systems for the qualitative detection of Methylenedioxymethamphetamine in human urine. EGENS Urine Test Marijuana (THC) uses immunochromatographic assays for Cannabinoids. These tests are lateral flow systems for the qualitative detection of Cannabinoids in human urine. Each test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
    Ask a Question
    K Number
    K151557
    Device Name
    EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine
    Manufacturer
    NANTONG EGENS BIOTECH CO., LTD.
    Date Cleared
    2015-07-16

    (36 days)

    Product Code
    DNK, LAF
    Regulation Number
    862.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    NANTONG EGENS BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EGENS Urine Test Cup Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively. EGENS Urine Test Cup Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. The EGENS Urine Test DipCard Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively. EGENS Urine Test DipCard Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
    Device Description
    EGENS Urine Test Morphine-Methamphetamine test uses immunochromatographic assays for Morphine and Methamphetamine. The test is a lateral flow system for the qualitative detection of Morphine and Methamphetamine in human urine. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
    Ask a Question

    Page 1 of 1