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510(k) Data Aggregation
K Number
K971502Device Name
SERODIA TP-PA
Manufacturer
Date Cleared
1997-11-13
(203 days)
Product Code
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
SCIMEDX TEKFILE SERVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Serodia-TP-PA is a qualitative gelatin particle agglutination assay intended to be used for the detection of Treponema pallidum antibodies in human serum or plasma as an aid in the diagnosis of syphilis. This product is not cleared or approved by the U.S. Food and Drug Administration (FDA) for use in screening blood or plasma donors.
Device Description
Particle Agglutination Test
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