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Found 6 results
510(k) Data Aggregation
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?
Product Code :
DDC
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
K012208Device Name
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2001-09-07
(53 days)
Product Code
DDC
Regulation Number
866.5870Why did this record match?
Product Code :
DDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access® Thyroglobulin Antibody (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access® Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease, nontoxic goiter, and Graves' disease.
Device Description
The Access Thyroglobulin Antibody reagents, Thyroglobulin Antibody calibrators, and the Access Immunoassay Analyzer comprise the Access Immunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.
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K Number
K000363Device Name
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
2000-02-18
(14 days)
Product Code
DDC
Regulation Number
866.5870Why did this record match?
Product Code :
DDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991610Device Name
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1999-06-25
(46 days)
Product Code
DDC
Regulation Number
866.5870Why did this record match?
Product Code :
DDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zeus Scientific, Inc. TPO (thyroid peroxidase) IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semiquantitative detection of IgG autoantibodies to human thyroid peroxidase in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.
Device Description
Not Found
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K Number
K991179Device Name
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1999-06-17
(71 days)
Product Code
DDC
Regulation Number
866.5870Why did this record match?
Product Code :
DDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zeus Scientific, Inc. Thyroglobulin IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgG autoantibodies to human thyroglobulin in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.
Device Description
Not Found
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K Number
K971835Device Name
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
Manufacturer
MONOBIND
Date Cleared
1997-07-03
(45 days)
Product Code
DDC
Regulation Number
866.5870Why did this record match?
Product Code :
DDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The quantitative determination of thyroglobulin autoantibodies in human serum or plasma by a microplate enzymeimmunoassay. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto, Graves, and nontoxic goiter.
Device Description
The Monobind method is based on ELISA technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing blotinylated thyroglobulin antigen, and a serum containing the autoantibody (anti-Tg), reaction results between the biotinylated thyroglobulin antigen and the antibodies to form an immune complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin, coated on the well, and biotinylated thyroglobulin antigen. After incubation is complete, decantation or aspiration separates the unbound components. The enzyme linked species specific antibody (anti-h-igG) is then added to the microwells. The anti-h-lgG enzyme conjugate that binds to the immobilized immune complex in a second incubation are separated from unreacted material by a wash step. The enzyme activity in this fraction Is directly proportional to the antibody concentration in the specimen. By utilizing several different serum references of known antibody activity, a reference curve can be generated from which the antibody activity of an unknown can be ascertained.
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