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510(k) Data Aggregation

    K Number
    K100031
    Device Name
    IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
    Manufacturer
    IND DIAGNOSTIC INC.
    Date Cleared
    2010-07-19

    (194 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTIC INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K063390
    Device Name
    URINE CHEMISTRY ANALYZER UR-50
    Manufacturer
    IND DIAGNOSTIC INC.
    Date Cleared
    2007-03-01

    (112 days)

    Product Code
    JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMT, JRE, KQO, LJX
    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTIC INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Urine Chemistry Analyzer UR-50 is for use with the IND Urinalysis Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite, leukocytes, pH, and specific gravity in urine. It can be used for testing in the clinical laboratory setting. For professional use only. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.
    Device Description
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    K Number
    K060810
    Device Name
    ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
    Manufacturer
    IND DIAGNOSTIC INC.
    Date Cleared
    2006-08-07

    (136 days)

    Product Code
    DKZ, DIO, DJG, LAF, LDJ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTIC INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mL Marijuana, 300 ng/mL Morphine, 1000 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetamine in urine in combinations (Multi-Panel) or separately (Single). It is not intended for over the counter sales to the lay person. For in vitro diagnostic use only. As with all qualitative tests, this assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method
    Device Description
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    K Number
    K052694
    Device Name
    ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
    Manufacturer
    IND DIAGNOSTIC INC.
    Date Cleared
    2005-12-16

    (79 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTIC INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    One Step HCG Pregnancy Test 2000 mIU / mL is a qualitative, two sites sandwich immunoassay test device for the determination of human chorionic gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL designed to aid in the detection of pregnancy. This test device is intended for professional central laboratory use only.
    Device Description
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    K Number
    K052662
    Device Name
    ONE STEP FSH MENOPAUSAL TEST
    Manufacturer
    IND DIAGNOSTIC INC.
    Date Cleared
    2005-11-30

    (64 days)

    Product Code
    CGJ
    Regulation Number
    862.1300
    Why did this record match?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTIC INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FSH Menopausal Test is a rapid Step The One chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of the onset of menopause. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH. This device is intended for both professional and lay person use.
    Device Description
    One Step FSH Menopausal Test is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH.
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    K Number
    K050741
    Device Name
    IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
    Manufacturer
    IND DIAGNOSTIC INC.
    Date Cleared
    2005-05-16

    (56 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTIC INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IND One Step hCG Pregnancy Test - Cassette Format is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are intended for professional use.
    Device Description
    Not Found
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    K Number
    K023638
    Device Name
    CASSETTE/URINE HCG
    Manufacturer
    IND DIAGNOSTIC INC.
    Date Cleared
    2003-01-03

    (65 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTIC INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    One Step urine hCG (cassette format) Pregnancy Test is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy. This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.
    Device Description
    Urine RCG (Cassette Format) One Step Test Kit
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