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Sources: EU EUDAMED, US FDA
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The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
FDA Enforcement
Class II
·Terminated·Diamedix Corporation·December 5, 2012
Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
FDA Enforcement
Class II
·Terminated·Diamedix Corporation·May 25, 2016
Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
FDA Enforcement
Class II
·Terminated·Diamedix Corporation·May 25, 2016
Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
FDA Enforcement
Class II
·Terminated·Diamedix Corporation·May 25, 2016
Diamedix Is-CMV IgG Test Kit
FDA Enforcement
Class II
·Terminated·Diamedix Corporation·May 25, 2016
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
FDA Enforcement
Class III
·Terminated·Diamedix Corporation·August 8, 2018
Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
FDA Enforcement
Class III
·Terminated·Diamedix Corporation·August 8, 2018