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Found 27 results
510(k) Data Aggregation
K Number
K132518Device 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
878.4810Why 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
K091260Device Name
SERAQUEST EBV EA-D IGG TEST
Manufacturer
QUEST INTL., INC.
Date Cleared
2009-06-08
(40 days)
Product Code
LSE
Regulation Number
866.3235Why 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
K033915Device Name
MODIFICATION TO SERAQUEST EB VCA IGG
Manufacturer
QUEST INTL., INC.
Date Cleared
2004-01-16
(29 days)
Product Code
LSE
Regulation Number
866.3235Why 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
K033780Device Name
MODIFICATION TO SERAQUEST VCA IGM
Manufacturer
QUEST INTL., INC.
Date Cleared
2004-01-15
(42 days)
Product Code
LJN
Regulation Number
866.3235Why 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
K023593Device Name
SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
Manufacturer
QUEST INTL., INC.
Date Cleared
2003-02-06
(104 days)
Product Code
JZO
Regulation Number
866.5870Why 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
K023592Device Name
SERAQUEST ANTI-THYROGLOBULIN
Manufacturer
QUEST INTL., INC.
Date Cleared
2003-01-06
(73 days)
Product Code
DDC
Regulation Number
866.5870Why 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
K003069Device Name
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
Manufacturer
QUEST INTL., INC.
Date Cleared
2000-11-27
(56 days)
Product Code
MID
Regulation Number
866.5660Why 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
K991975Device Name
SERAQUEST EB NA IGG
Manufacturer
QUEST INTL., INC.
Date Cleared
1999-11-02
(144 days)
Product Code
LSE
Regulation Number
866.3235Why 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
K990410Device Name
SERAQUEST EB VCA IGG
Manufacturer
QUEST INTL., INC.
Date Cleared
1999-10-28
(261 days)
Product Code
LSE
Regulation Number
866.3235Why 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
K990977Device Name
SERAQUEST EB VAC IGM
Manufacturer
QUEST INTL., INC.
Date Cleared
1999-10-06
(197 days)
Product Code
LJN
Regulation Number
866.3235Why 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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