FDA.reportPublic FDA data

Immunoglobulin A subclass (IgA subclass) 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 one or multiple immunoglobulin A subclasses (IgA subclasses) in a clinical specimen.
GUDID devices
6
Last updated
2025-03-26 08:21:28

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B502BSB9233CS0IgA Control SlidesBIO SB, INC.BSB-9233-CS2025-03-18
07613389527353Unitron BrandSonova AG050-6474-P62022-06-10
07613389528084Unitron BrandSonova AG050-6473-R82022-06-10
07613389480443Phonak BrandSonova AG050-1009-4A2022-04-01
05051700019262Optilite® IgA2 Control PackTHE BINDING SITE GROUP LIMITEDNQ088.OPT2018-01-26
05051700019330Optilite® IgA1 Control PackTHE BINDING SITE GROUP LIMITEDNQ087.OPT2017-09-06