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510(k) Data Aggregation

    K Number
    K030730
    Device Name
    FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT
    Manufacturer
    DIAGNOSTICS BIOCHEM CANADA, INC.
    Date Cleared
    2003-08-18

    (161 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTICS BIOCHEM CANADA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dbc CAN-fTE-260 EiAsy™ Free Testosterone enzymeimmunoassay (EiA) kit provides the reagents necessary for the direct determination of Free Testosterone in human serum. This assay is intended for in vitro diagnostic use only. Measurement of Free Testosterone are used in the diagnosis in male sex hormones (androgens) and in females hirsutism (excessive hair) and virilisation (masculinization).
    Device Description
    The free Testosterone Elisa kit consists of one polyclonal antibody which is coated on microtiter plate (96 wells per kit). The antigen Testosterone 3 carboxymethyl oxime is conjugated to an enzyme namely horse radish peroxidase. The standards are prepared in human serum matrix and all other reagents within the kit namely assay buffer, wash buffer concentrate, substrate tetramet hytbenzidine (TMB) and stopping solution. 50 ul of patient serum , control serum and each standard are added to each well. 100 ul of conjugate solution is again added to each well. The incubation time is 37°C for 60 minutes. After incubation the plates are washed 3 times, each time with 300 ul of diluted wash buffer. The plates are dried. 100 ul of substrate TMB is added to each well and allowed to incubate for 10 - 15 minutes at 37°C. 50 ul of stopping solution is added into each well and the colour becomes yellow. The plate is read within 20 minutes in a microtiter plate reader at 450 nm.
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    K Number
    K014120
    Device Name
    TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
    Manufacturer
    DIAGNOSTICS BIOCHEM CANADA, INC.
    Date Cleared
    2002-02-08

    (53 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTICS BIOCHEM CANADA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dbc CAN-TE-250 EiAsy™ Testosterone enzymeimmunoassay (EiA) kit provides the reagents necessary for the direct determination of Testosterone in human serum The use of this assay is intended for in vitro diagnostic use only. Measurement of Testosterone are used in the diagnosis and treatment of disorders involving the male sex hormone (androgens), including primary and secondary hypogonadism, delayed or precocious puberty impotence in male and in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adrenogenital syndromes.
    Device Description
    The Testosterone (total) Elisa kit consists of one polyclonal antibody which is coated on microtiter plate (96 wells per kit). The antigen Testosterone 3 carboxymethyl oxime is conjugated to an enzyme namely horse radish peroxidase. The standards are prepared from protein base matrix and all other reagents within a kit namely assay buffer, wash buffer concentrate, substrate tetramethetbenzidine (TMB) and stopping solution. The incubation time is 60 minutes at room temperature. 25 ul of patient serum , control serum and each standard are added for each assay. After incubation the plates are washed 3 times, each time with 300 ul of diluted wash buffer. The plates are dried. 150 ul of TMB is added to each well and allowed to incubate for 10 - 15 minutes. 50 ul of stopping solution is added into each well and the colour becomes yellow. The plate is read within 20 minutes in a microtiter plate reader at 450 mm.
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