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510(k) Data Aggregation

    K Number
    K001943
    Device Name
    CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
    Manufacturer
    SANGUI BIOTECH, INC.
    Date Cleared
    2000-08-23

    (58 days)

    Product Code
    NAO
    Regulation Number
    862.1360
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANGUI BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992799
    Device Name
    SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
    Manufacturer
    SANGUI BIOTECH, INC.
    Date Cleared
    2000-06-07

    (293 days)

    Product Code
    GGT
    Regulation Number
    864.7250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANGUI BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this product is the quantitative determination of erythropoietin levels in human serum. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
    Device Description
    Quantitative determination of EPO [Erythropoietin] in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
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    K Number
    K982491
    Device Name
    SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
    Manufacturer
    SANGUI BIOTECH, INC.
    Date Cleared
    1998-09-03

    (48 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANGUI BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this product is the quantitative determination of Calcitonin in human serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
    Device Description
    Quantitative determination of Calcitonin in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
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    K Number
    K982608
    Device Name
    SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
    Manufacturer
    SANGUI BIOTECH, INC.
    Date Cleared
    1998-08-19

    (23 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANGUI BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this product is the quantitative determination of ACTH [Adrenocorticotropic Hormone] in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
    Device Description
    Quantitative determination of ACTH in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
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    K Number
    K974306
    Device Name
    SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
    Manufacturer
    SANGUI BIOTECH, INC.
    Date Cleared
    1997-12-23

    (36 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANGUI BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this product is the quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA). The measurement of parathyroid hormone levels in the disease states is intended for the differential diagnosis of hypercalcemia and hypocalcemia resulting from the disorders of calcium metabolism.
    Device Description
    Quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
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