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510(k) Data Aggregation

    K Number
    K132518
    Device Name
    NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
    Manufacturer
    WELLQUEST INTL., INC.
    Date Cleared
    2014-08-17

    (370 days)

    Product Code
    OHT, DEV, ONF
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELLQUEST INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wellquest NuBrilliance Pulsed Light Hair Removal system device is an over-the-counter device intended for the removal of unwanted hair. The NuBrilliance Pulsed Light Hair Removal System is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of the treatment regimen.
    Device Description
    The NuBrilliance Pulsed Light Hair Removal System is a home-use, medical-esthetic device for long term Hair Reduction based on Intensive Pulse Light (IPL) technology. The NuBrilliance Pulsed Light Hair Removal System works below the skin's surface and therefore does not involve any cutting or pulling, reducing pain and preventing new hair growth. The NuBrilliance Pulsed Light Hair Removal System consists of the following main components: Base unit and applicator, Base-Applicator cable, and an AC cord. The Base Unit comprises the User Interface (display/LEDs, buttons, etc.), the connection cable to the Applicator, the power cable to the grid as well as internal parts such electronics board/s and mechanical parts (fans, holders, etc.). The Applicator is a hand held part used to remove unwanted body hair by applying the Nu Brilliance Pulsed Light Hair Removal treatment on areas such underarms, bikini line, arms and legs. It comprises a triggering button, a replaceable lamp sub-assembly, an optical safety feature as well as internal electro-mechanical parts. The replaceable lamp cartridge is located inside the applicator inner body. The Base Unit provides the User Interface which includes the following controls: - . Power on/off button - . Energy level selection button ("-" or "+") - Six energy level lights - lights up green when energy level is determined - . Cartridge lamp – slowly flashes red when the cartridge requires replacement
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    K Number
    K091260
    Device Name
    SERAQUEST EBV EA-D IGG TEST
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    2009-06-08

    (40 days)

    Product Code
    LSE
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUEST INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SeraQuest EBV EA-D IgG test is for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum by enzyme immunoassay. This assay uses a 28 kd E. coli expressed recombinant Epstein-Barr virus early antigen. When performed in conjunction with other EBV serological tests, this assay can be used as an aid in the laboratory diagnosis of EBV infectious mononucleosis in patients with signs and symptoms of EBV infectious mononucleosis. For In Vitro Diagnostic Use Only.
    Device Description
    The SeraQuest EBV EA-D IgG Test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against EBV Early Antigen D (EA-D), in human serum.
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    K Number
    K033915
    Device Name
    MODIFICATION TO SERAQUEST EB VCA IGG
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    2004-01-16

    (29 days)

    Product Code
    LSE
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUEST INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. For In Vitro Diagnostic Use - 2. For the qualitative and semi-quantitative detection of human IgG antibodies to Epstein-Barr (EB) viral capsid antigen (VCA) in human serum by enzyme immunoassay. - 3. For use as an aid in differentiating active or recent infection, from past infection.
    Device Description
    The SeraQuest EB VCA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum. The Calibrators in the SeraQuest EB VCA IgG test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
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    K Number
    K033780
    Device Name
    MODIFICATION TO SERAQUEST VCA IGM
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    2004-01-15

    (42 days)

    Product Code
    LJN
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUEST INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For in vitro diagnostic use only.
    Device Description
    The SeraQuest VCA IgM test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgM antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum. The Calibrators in the SeraQuest VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
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    K Number
    K023593
    Device Name
    SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    2003-02-06

    (104 days)

    Product Code
    JZO
    Regulation Number
    866.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUEST INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative detection of IqG antibodies to thyroid peroxidase in human serum by enzyme immunoassay. The SeraQuest Anti-thyroid peroxidase test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease. For in vitro diagnostic use only.
    Device Description
    The SeraQuest Anti-Thyroid Peroxidase test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minutes incubations. It has been developed to detect IgG antibodies which are directed against Thyroid Peroxidase, in human serum. The Calibrators in the SeraQuest Anti-Thyroid Peroxidase test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).
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    K Number
    K023592
    Device Name
    SERAQUEST ANTI-THYROGLOBULIN
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    2003-01-06

    (73 days)

    Product Code
    DDC
    Regulation Number
    866.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUEST INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. For the quantitative detection of IqG antibodies to thyroglobulin in human serum by enzyme immunoassay. 2. The SeraQuest Anti-thyroglobulin test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease. 3. For in vitro diagnostic use only.
    Device Description
    The SeraQuest Anti-Thyroglobulin test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IqG antibodies which are directed against thyroglobulin, in human serum. The Calibrators in the SeraQuest Anti-Thyroglobulin test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).
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    K Number
    K003069
    Device Name
    ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    2000-11-27

    (56 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUEST INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991975
    Device Name
    SERAQUEST EB NA IGG
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    1999-11-02

    (144 days)

    Product Code
    LSE
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUEST INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr virus nuclear antigen in human serum by enzyme immunoassay. May be used in conjunction with other EBV serologicals as an aid in the diagnosis of infectious mononucleosis.
    Device Description
    The SeraQuest EB NA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Epstein-Barr virus nuclear antigen, in human serum. The Calibrators in the SeraQuest EB NA IgG test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
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    K Number
    K990410
    Device Name
    SERAQUEST EB VCA IGG
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    1999-10-28

    (261 days)

    Product Code
    LSE
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUEST INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. For in vitro diagnostic use only. 2. For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr viral capsid antigen (VCA) in human serum by enzyme immunoassay. 3. For use as an aid in differentiating active or recent infection, from past infection. 4. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.
    Device Description
    The SeraQuest EB VCA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Epstein-Barr virus capsid antigen.
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    K Number
    K990977
    Device Name
    SERAQUEST EB VAC IGM
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    1999-10-06

    (197 days)

    Product Code
    LJN
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUEST INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. 2. For in vitro diagnostic use only. 3. A positive result is presumptive for the detection of anti-Epstein-Barr virus IgM antibodies and presumptive for the diagnosis of acute or recent Epstein-Barr virus infection.
    Device Description
    The SeraQuest EB VCA IgM test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgM antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum. The Calibrators in the SeraQuest EB VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
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