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510(k) Data Aggregation

    K Number
    K974721
    Device Name
    UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
    Manufacturer
    BAYER CORP.
    Date Cleared
    1998-03-03

    (75 days)

    Product Code
    CGI
    Regulation Number
    862.1265
    Why did this record match?
    Product Code :

    CGI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol (uE¿) in human serum on the Bayer Immuno 1™ system. Measurements of uE, are used in evaluating fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation. This diagnostic method is not intended for use on any other system.
    Device Description
    This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol in human serum on the Bayer Immuno 1 System.
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    K Number
    K962875
    Device Name
    ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1996-08-23

    (30 days)

    Product Code
    CGI
    Regulation Number
    862.1265
    Why did this record match?
    Product Code :

    CGI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL EIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconjugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.
    Device Description
    The DSL Ultra-Sensitive Unconjugated Estriol EIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The ElA format is a competitive binding protein assay. Horseradish peroxidase labelled unconiugated estriol competes with un-labeled Unconjugated Estrict in the serum sample for antibody binding sites. After incubation and washing the wells are incubated with the substrate tetramethylbenzidine (TMB). An acidic stopping solution is then added and the decree of enzymatic turnover of the substrate is determined by dual wavelength absorbance measurement.
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    K Number
    K955356
    Device Name
    ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1996-05-15

    (176 days)

    Product Code
    CGI
    Regulation Number
    862.1265
    Why did this record match?
    Product Code :

    CGI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconiugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.
    Device Description
    The DSL Ultra-Sensitive Unconjugated Estriol RIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The RIA format is a competitive binding protein assav. Radio-labeled Unconjugated Estriol competes with un-labeled Unconjugated Estriol in the serum sample for binding sites on the antibody coated tubes. Separation of free from bound Unconjugated Estriol is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled estriol bound to the antibody is inversely proportional to the concentration of the estricl present in the sample.
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