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510(k) Data Aggregation

    K Number
    K971304
    Device Name
    QUANTA LITE REBELLA IGG
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1998-01-02

    (269 days)

    Product Code
    LFX
    Regulation Number
    866.3510
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QUANTA Lite™ Rubella IgG kit is intended as an in vitro diagnostic assay for the semi-quantitative or quantitative detection rubella IgG antibodies in single sera for evaluation of immune status or in paired sera to demonstrate seroconversion.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the QUANTA Lite™ RUBELLA IgG ELISA test kit. It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The letter primarily states that the device is substantially equivalent to a predicate device and can be marketed.

    Therefore, I cannot extract the requested information from the provided text.

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