FDA.reportPublic FDA data

Epstein-Barr virus (EBV) nucleic acid IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Epstein-Barr virus (EBV) in a clinical specimen.
GUDID devices
6
Last updated
2024-04-15 12:53:33

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
15420045512122Panther Fusion®Hologic, Inc.LBLD, EBV PLASMID (UNASSAYED CONTROL)2024-04-05
00884999049499Alinity mABBOTT MOLECULAR INC.09N43-0852022-08-29
00884883006423Acrometrix EBV Low Plasma ControlMicrogenics Corporation9612302018-06-09
00884883006430Acrometrix EBV High Plasma ControlMicrogenics Corporation9612312018-06-09
00812242030154Exact DiagnosticsEXACT DIAGNOSTICS, LLCEBVL1012018-09-24
00812242030161Exact DiagnosticsEXACT DIAGNOSTICS, LLCEBVH1022018-09-24