Diamedix Corporation

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2573-2018Class IIIDiamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540January 5, 2018
Z-2574-2018Class IIIDiamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640January 5, 2018
Z-1689-2016Class IIDiamedix Is-CMV IgG Test KitMarch 26, 2015
Z-1687-2016Class IIDiamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended foOctober 20, 2014
Z-1685-2016Class IIDiamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for tOctober 20, 2014
Z-1686-2016Class IIDiamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended forOctober 20, 2014
Z-0445-2013Class IIThe Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test KitAugust 6, 2012