FDA.reportPublic FDA data

Enterovirus nucleic acid (serotypes 68-71) 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 one or multiple enteroviruses from serotypes 68-71 in a clinical specimen.
GUDID devices
4
Last updated
2020-10-26 15:31:30

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
01220000260160NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Enterovirus Positive Control2020-10-16
01220000260177NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Enterovirus Negative Control 2020-10-16
00884883006515Acrometrix EV Negative ControlMicrogenics Corporation9604992018-06-15
00884883006522Acrometrix EV Low ControlMicrogenics Corporation9605012018-06-15