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Found 10 results
510(k) Data Aggregation
K Number
K010301Device Name
IMMUNOWELL EA (D) IGG TEST
Manufacturer
GenBio
Date Cleared
2001-06-11
(130 days)
Product Code
LSE
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
GenBio
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K974226Device Name
IMMUNODOT MONO-G TEST
Manufacturer
GenBio
Date Cleared
1998-09-22
(314 days)
Product Code
LSE
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
GenBio
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mono G Test is a qualitative enzyme immunoassay (EIA) that detects IgG antibodies to Epstein-Barr virus capsid antigen (EBV-VCA), Epstein-Barr early nuclear antigen (EBV-EBNA), cytomegalovirus (CMV), and toxoplasma (toxo). When used in conjunction with Mono-M Test it is an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV or toxoplasma mononucleosis-like syndrome.
This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).
Device Description
The product is an ELISA test method detecting viral capsid antigen Epstein-Barr nuclear antigen, cytomegalovirus and toxoplasma IgG antibodies.
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K Number
K974244Device Name
IMMUNODOT MONO-M TEST
Manufacturer
GenBio
Date Cleared
1998-09-22
(314 days)
Product Code
LSE
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
GenBio
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mono M Test is a qualitative enzyme immunoassay (EIA) that detects IgM antibodies to Paul-Bunnell heterophil, Epstein-Barr virus capsid antigen (EBV-VCA), and cytomegalovirus (CMV). When used in conjunction with Mono-G Test, it is as an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome.
This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).
Device Description
The product is an ELISA test method detecting heterophile, viral capsid antigen and cytomegalovirus IgM antibodies.
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K Number
K973939Device Name
IMMUNOWELL VCA IGM TEST
Manufacturer
GenBio
Date Cleared
1998-08-10
(299 days)
Product Code
LJN
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
GenBio
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ImmunoWELL VCA IgM Test is for the qualitative detection of IgM antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).
Device Description
Microtiter ELISA kit detecting VCA IgM antibodies
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K Number
K973940Device Name
IMMUNOWELL EBV VCA IGG TEST
Manufacturer
GenBio
Date Cleared
1998-08-10
(299 days)
Product Code
LSE
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
GenBio
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ImmunoWELL. VCA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgG test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgM, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).
Device Description
Microtiter ELISA kit detecting VCA IgG antibodies
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K Number
K973941Device Name
IMMUNOWELL EBNA IGG TEST
Manufacturer
GenBio
Date Cleared
1998-08-10
(299 days)
Product Code
LLM
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
GenBio
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ImmunoWELL EBNA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus nuclear antigen-1 (EBNA-1) in human serum by ELISA. When the EBNA IgG test is used in conjunction with other testing such as the EBV viral capsid IgG or IgM, EBV early antigen IgG tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM) and the stage of EBV infection in adults and children.
Device Description
Microtiter ELISA kit detecting EBNA antibodies
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K Number
K963054Device Name
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
Manufacturer
GenBio
Date Cleared
1997-05-05
(272 days)
Product Code
LJZ
Regulation Number
866.3375Why did this record match?
Applicant Name (Manufacturer) :
GenBio
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K963055Device Name
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
Manufacturer
GenBio
Date Cleared
1997-05-02
(269 days)
Product Code
LJZ
Regulation Number
866.3375Why did this record match?
Applicant Name (Manufacturer) :
GenBio
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K953682Device Name
IMMUNO DOT BORRELIA DOT BLOT G TEST
Manufacturer
GenBio
Date Cleared
1996-05-03
(270 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
GenBio
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K953683Device Name
MMUNO DOT BORRELIA DOT BLOT M TEST
Manufacturer
GenBio
Date Cleared
1996-05-03
(270 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
GenBio
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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