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510(k) Data Aggregation
K Number
K984126Device Name
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
Manufacturer
Date Cleared
1999-01-11
(54 days)
Regulation Number
866.3235Why did this record match?
Product Code :
MCD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This test system is designed for the manual or automated, qualitative detection of IqG antibodies to EBV-VCA in human serum specimens. When used with other EBV serologies such as Heterophile, EBNA IgG an VCA IgM, this test system may aid in the diagnosis and provide information on infectious mononucleosis that may be of value in patient management and treatment. The test is for in vitro diagnostic use,
Device Description
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