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510(k) Data Aggregation

    K Number
    K041619
    Device Name
    BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    2004-12-17

    (185 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHECK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test İs intended for the qualitative determination of cardiac troponin I in human whole blood, plasma or serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).
    Device Description
    The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test is a colloidal gold/antibody conjugatebased immunoassay designed for the detection of cTnl in human whole blood, plasma and serum samples. To perform the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test, the sample is dispensed into the sample well. The red cells in the whole blood will react with certain biochemical reagents (such as anti-red blood cells) which are immobilized in the sample pad. This reaction will cause the red blood cells to bind to the sample pad, allowing only the plasma to travel forward. CTnl that is present in the specimen is bound by a gold-antibody conjugate forming a gold-antibody-antigen complex. This complex migrates across the membrane by capillary action and reacts with three anticTnl monoclonal antibodies immobilized in the test region to produce a pink color band when the cTnl concentration is equal to or greater than 1.5 ng/ml. If cTnl is not present in the specimen, there is no line in the test line area. The mixture continues to migrate to the procedural control line area and produce a pink color band. If no procedural control line is present, the sample is invalid and should be retested.
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    K Number
    K040030
    Device Name
    BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    2004-06-16

    (161 days)

    Product Code
    DCN
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHECK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioCheck CRP Rapid Test is intended for the qualitative detection of C-reactive protein (CRP) in human serum. Measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
    Device Description
    The BioCheck CRP Rapid Test is a colloidal gold/antibody conjugate-based immunoassay designed for the detection of CRP in human serum samples. To perform the serum CRP test, serum is added to the Sample Well. CRP in the specimen is bound by a gold-antibody conjugate forming a gold-antigen complex. This complex migrates across the membrane by capillary action and reacts with a goat anti-human CRP polyclonal antibody immobilized in the test region to produce a pink color band when the CRP concentration is equal to or greater than 4.0 mg/L. If the CRP concentration is less than 4.0 mg/L, there is no line in the test line area. The gold-conjugate continues to migrate to the control line area and produce a pink color band, indicating a valid test.
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    K Number
    K022660
    Device Name
    BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    2002-12-19

    (132 days)

    Product Code
    DRR
    Regulation Number
    870.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHECK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioCheck Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
    Device Description
    Not Found
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    K Number
    K013062
    Device Name
    BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    2002-01-08

    (118 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHECK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioCheck cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).
    Device Description
    Not Found
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    K Number
    K003851
    Device Name
    BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    2001-07-20

    (220 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHECK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002294
    Device Name
    BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    2000-10-02

    (67 days)

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

    BIOCHECK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001022
    Device Name
    BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    2000-09-26

    (180 days)

    Product Code
    JZG
    Regulation Number
    866.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHECK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992517
    Device Name
    BIOCHECK FERRITIN ELISA MODEL BC-1025
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    1999-09-24

    (58 days)

    Product Code
    DBF
    Regulation Number
    866.5340
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHECK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioCheck Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism.
    Device Description
    BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit Model BC-1025
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    K Number
    K992528
    Device Name
    BIOCHECK IGE ELISA, MODEL BC-1035
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    1999-09-21

    (55 days)

    Product Code
    DGC
    Regulation Number
    866.5510
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHECK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioCheck IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
    Device Description
    BioCheck, Inc. Immunoglobulin E (IgE) Enzyme Immunoassay Test Kit (IgE-ELISA)
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    K Number
    K991741
    Device Name
    BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    1999-07-22

    (62 days)

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

    BIOCHECK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioCheck hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) in serum. This assay is to be used for the early detection of pregnancy in a clinical laboratory setting.
    Device Description
    BioCheck human Chorionic Gonadotropin Enzyme Immunoassay Test Kit (hCG-ELISA)
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