Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K141100
    Device Name
    OPTILITE C1 INACTIVATOR KIT
    Manufacturer
    THE BINDING SITE GROUP LTD
    Date Cleared
    2014-07-18

    (80 days)

    Product Code
    DBA
    Regulation Number
    866.5250
    Why did this record match?
    Product Code :

    DBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optilite Cl Inactivator Kit is intended for the quantitative in vitro measurement of human C1 Inactivator in human serum using the Binding Site Optilite analyser. Measurement of CI inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
    Ask a Question
    K Number
    K122304
    Device Name
    HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-04-15

    (257 days)

    Product Code
    DBA
    Regulation Number
    866.5250
    Why did this record match?
    Product Code :

    DBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Human C1 Inactivator kit for use on SPAPLUS is intended for the in vitro measurement of human C1 inactivator in human serum using the SPAPLUS Analyzer. Measurement of C1 inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
    Ask a Question
    K Number
    K072965
    Device Name
    DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2007-12-21

    (60 days)

    Product Code
    DBA, JIT, JJX
    Regulation Number
    866.5250
    Why did this record match?
    Product Code :

    DBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dimension Vista® C1IN Flex® reagent cartridge: The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer). Dimension Vista® C1IN CAL: The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (C1IN) method on the Dimension Vista® System. Dimension Vista® C1IN CON: C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of C1 Inhibitor (C1IN).
    Device Description
    Dimension Vista® C1IN Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration. Dimension Vista® C1IN CAL: C1 Calibrator is a lyophilized, human plasma based product containing C1 Inhibitor (C1IN). Dimension Vista® C1IN CON: C1 Control is a lyophilized, mid-level, human plasma based products containing C1 Inhibitor (C1IN).
    Ask a Question
    K Number
    K011780
    Device Name
    K-ASSAY C1-INA
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2001-07-25

    (48 days)

    Product Code
    DBA
    Regulation Number
    866.5250
    Why did this record match?
    Product Code :

    DBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY C1-INA Assay is intended for the quantitative determination of human Complement-1 Inactivators in human plasma by immunoturbidimetric assay for hereditary angioedema. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    Not Found
    Ask a Question
    K Number
    K003747
    Device Name
    C1-INHIBITOR MICROTITER ASSAY DEVICE
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    2001-03-19

    (105 days)

    Product Code
    DBA
    Regulation Number
    866.5250
    Why did this record match?
    Product Code :

    DBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K965024
    Device Name
    N-ASSAY TIA C1-INACTIVATOR TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-07-14

    (209 days)

    Product Code
    DBA
    Regulation Number
    866.5250
    Why did this record match?
    Product Code :

    DBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-Assay TIA C1 Inactivator Test Kit is intended to be used for the quantification of Cl Inactivator in human plasma. Cl Inactivator is measured by immunoturbidimetric assay. Measurement of Complement I Inhibitor aids in the diagnosis of hereditary angioneurotic edema and a rare form of angioedema associated with lymphoma.
    Device Description
    Not Found
    Ask a Question
    K Number
    K960257
    Device Name
    N ANTISERUM TO C1 INHIBITOR
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1996-08-01

    (196 days)

    Product Code
    DBA
    Regulation Number
    866.5250
    Why did this record match?
    Product Code :

    DBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
    Device Description
    In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of anqioedema associated with lymphoma (lymph node cancer). In an immunochemical reaction, C1 Inhibitor in the human plasma sample form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
    Ask a Question

    Page 1 of 1