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510(k) Data Aggregation
K Number
K981263Device Name
TOXOGEN
Manufacturer
Date Cleared
1998-08-06
(121 days)
Product Code
Regulation Number
866.3780Why did this record match?
Product Code :
GMM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The test may be used with a single specimen to estimate the immunologic response of the individual or with paired acute and convalescent sera as an aid in the diagnosis of primary, acute or reactivated toxoplasmosis. This assay is not FDA cleared for use in blood or plasma donor screening.
Device Description
Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The new Toxogen is a modified version of the predicate Toxogen with a larger latex particle size to increase sensitivity from 10 IU/mL to 5 IU/mL.
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