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510(k) Data Aggregation

    K Number
    K003794
    Device Name
    ELISA TEST, SEROLOGY
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2001-03-30

    (112 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002358
    Device Name
    MDI GLIADIN A TEST
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-10-19

    (78 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002359
    Device Name
    MDI GLIADIN G TEST
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-10-19

    (78 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000934
    Device Name
    MDI SCL-70 TEST
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-04-07

    (15 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000477
    Device Name
    MDI DS-DNA TEST
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-03-01

    (16 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K993843
    Device Name
    MDI RF TEST
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-01-11

    (60 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDI RF Test is a semi quantitative Enzyme Immunoassay (EIA) Kit for the detection of IgM antibodies against human IgG (RF) in human serum. The test is intended as an aid in the diagnosis of rheumatoid arthritis. FOR IN VITRO DIAGNOSTIC USE ONLY.
    Device Description
    The Micro Detect, Inc. RF reagent ( MDI RF Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.
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    K Number
    K993971
    Device Name
    MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-01-11

    (49 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDI SS-B Test reagents (P/N; SBKi-G) are intended for the semi-quantitative determination of IgG antibodies to SS-B in human serum. The principal diagnostic value of this test is detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases. The MDI SS-B Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human SS-B in human serum The test is intended as an aid in the diagnosis of rheumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.
    Device Description
    The Micro Detect, Inc. SS-B reagent ( MDI SS-B Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls. Wash Buffer. Sample Diluent, Conjugate, Substrate, and Stop Solution.
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    K Number
    K994029
    Device Name
    MDI SM TEST
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-01-11

    (46 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDI Sm Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human Sm in human serum. The test is intended as an aid in the diagnosis of theumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.
    Device Description
    The Micro Detect, Inc. Sm reagent ( MDI Sm Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.
    Ask a Question
    K Number
    K993635
    Device Name
    MDI SM/RNP TEST
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-01-10

    (75 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDI Sm/RNP Test reagents (P/N: RNKi-G) are intended for the semi quantitative determination of IgG antibodies to Sm/RNP in human serum. The principal diagnostic value of this test is detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases. The MDI Sm/RNP Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human Sm/RNP in human serum. The test is intended as an aid in the diagnosis of theumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.
    Device Description
    The Micro Detect, Inc. Sm/RNP reagent ( MDI Sm/RNP Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.
    Ask a Question
    K Number
    K993636
    Device Name
    MDI SS-A TEST
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-01-10

    (75 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDI SS-A Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human SS-A in human serum. The test is intended as an aid in the diagnosis of rheumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.
    Device Description
    The Micro Detect, Inc. SS-A reagent ( MDI SS-A Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.
    Ask a Question

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