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510(k) Data Aggregation
K Number
K972406Device Name
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
Manufacturer
IMMUNO PROBE, INC.
Date Cleared
1997-12-22
(179 days)
Product Code
GOD
Regulation Number
866.3020Why did this record match?
Applicant Name (Manufacturer) :
IMMUNO PROBE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Adenovirus Antigen Detection ELISA Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of Adenovirus antigen in human fecal samples as an aid in the diagnosis of acute non-bacterial gastro-enteritis. Performance for this assay has not been established on children over the age of five and immunocompromised patients. The antibody utilized in this assay is a group specific antigen and cannot differentiate between types of adenovirus. Performance of this assay has not been established for specimens other than human feces. For in vitro diagnostic use only.
Device Description
The Adenovirus Antigen Detection ELISA test is an enzyme linked immunosorbent assay to detect adenovirus antigen in fecal samples. Purified monoclonal antibody specific to adenovirus is attached to a solid phase microtiter well. Diluted fecal sample is added to each well. If the adenovirus antigen is present, it will bind to the monoclonal antibody in the well. After incubation the wells are washed to remove unbound antigen. An enzyme labeled anti-adenovirus polyclonal antibody is added to each well. If antigen is present the conjugate antibody will bind to the antigen attached to the antibody on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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K Number
K971393Device Name
MYCOPLASMA IGG ELISA TEST SYSTEM
Manufacturer
IMMUNO PROBE, INC.
Date Cleared
1997-07-14
(96 days)
Product Code
LJZ
Regulation Number
866.3375Why did this record match?
Applicant Name (Manufacturer) :
IMMUNO PROBE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mycoptasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.
Device Description
The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semiquantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For In Vitro Diagnostic Use Only.
The Mycoplasma IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Mycoplasma pneumoniae. Purified Mycoplasma pneumoniae antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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K Number
K961764Device Name
PR-3 ELISA TEST SYSTEM
Manufacturer
IMMUNO PROBE, INC.
Date Cleared
1996-08-19
(104 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
IMMUNO PROBE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE.
Device Description
The PR-3 ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to Proteinase-3 in human sera. The PR-3 ELISA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to Proteinase-3. Purified PR-3 is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG, M, A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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K Number
K961765Device Name
MPO ELISA TEST SYSTEM
Manufacturer
IMMUNO PROBE, INC.
Date Cleared
1996-08-19
(104 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
IMMUNO PROBE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.
Device Description
The MPO EIA test is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of antibodies to myeloperoxidase in human sera. The MPO EIA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to myeloperoxidase. Purified MPO is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG. M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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K Number
K951549Device Name
EBNA IGG EIA TEST SYSTEM
Manufacturer
IMMUNO PROBE, INC.
Date Cleared
1996-04-29
(391 days)
Product Code
LLM
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
IMMUNO PROBE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ImmunoProbe anti-EBNA-1 IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA (R&D), and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.
Device Description
The Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgG kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the semi-quantitative determination of IgG antibodies in human serum to EBNA-1 antigen. The EBNA-1 IgG EIA test is an enzyme linked immunosorbent assay to detect IgG antibodies to EBNA-1. Purified recombinant EBNA-1 is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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K Number
K952521Device Name
CARDIOLIPIN IGM EIA TEST SYSTEM
Manufacturer
IMMUNO PROBE, INC.
Date Cleared
1996-02-09
(253 days)
Product Code
MID
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
IMMUNO PROBE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K952522Device Name
CARDIOLIPIN IGA EIA TEST SYSTEM
Manufacturer
IMMUNO PROBE, INC.
Date Cleared
1996-02-09
(253 days)
Product Code
MID
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
IMMUNO PROBE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K952523Device Name
CARDIOLIPIN IGG EIA TEST KIT
Manufacturer
IMMUNO PROBE, INC.
Date Cleared
1996-02-09
(253 days)
Product Code
MID
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
IMMUNO PROBE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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