FDA.reportPublic FDA data

Norovirus 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 Norovirus in a clinical specimen.
GUDID devices
5
Last updated
2020-10-26 15:31:30

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
01220000260108NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Norovirus GI/GII Positive Control 2020-10-16
01220000260115NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Norovirus GI Positive Control2020-10-16
01220000260122NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Norovirus GII Positive Control 2020-10-16
01220000260139NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Norovirus Negative Control2020-10-16
70845357041400QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82052020-04-30