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510(k) Data Aggregation

    K Number
    K964014
    Device Name
    KENLOR H. PYLORI CONTROL SERUM
    Date Cleared
    1997-03-03

    (147 days)

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

    KENLOR INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    KENLOR H. pylori Serum Control is designed to provide unassayed precision control reagents. The controls are to be used with the in vitro immunoassay procedures for the qualitative determination of Helicobacter pylori IgG antibody in human serum assays. The controls are designed for routine use to provide a means of estimating precision and monitoring system performance. The controls are not intended to replace reagent controls furnished with the commercial kits. The control should be used like a patient sample to assist in the assessment of the listed analytical procedures. The usefulness of Quality Control materials for monitoring the accuracy and precision of clinical testing is well documented.
    Device Description
    Ready to use stabilized, Liquid Serum Control for qualitative determination of Helicobacter pylori IgG antibody in human serum assays. The controls contain 0.05% Sodium azide as preservative. The human source material is from human Serum and protein fractions of human serum.
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