FDA.reportPublic FDA data

Beta-haemolytic Group A Streptococcus antigen 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 antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.
GUDID devices
3
Last updated
2020-09-24 08:41:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10811877010446BinaxNOW Strep A Control Swab PackAlere Scarborough, Inc.730-0102020-09-16
30014613003540QuickVueQUIDEL CORPORATION003542019-04-02
30014613003458QuickVue In-LineQUIDEL CORPORATION003452019-03-21