FDA.reportPublic FDA data

Total immunoglobulin M (IgM total) 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 total immunoglobulin M (IgM total) in a clinical specimen.
GUDID devices
9
Last updated
2025-03-04 15:09:25

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B502BSB36870IgM control slidesBIO SB, INC.Control Slides, 5 2020-06-30
B502BSB56860IgM control slidesBIO SB, INC.Control Slides, 52020-06-30
B502BSB3008CS0IgM / FITC control slidesBIO SB, INC.control slides, 5 2020-09-30
L502BSB3687IgM control slidesBIO SB, INC.Control Slides, 5 2020-06-30
L502BSB5686IgM control slidesBIO SB, INC.Control Slides, 52020-06-30
05051700018883Human IgM Control Pack for use on the SPAPLUS®THE BINDING SITE GROUP LIMITEDNQ012.S2017-06-05
05051700019118Optilite® IgM Control PackTHE BINDING SITE GROUP LIMITEDNQ012.OPT2017-08-02
05051700019446Optilite® Hevylite® IgM Kappa Control PackTHE BINDING SITE GROUP LIMITEDNQ625.OPT2017-09-06
05051700019453Optilite® Hevylite® IgM Lambda Control PackTHE BINDING SITE GROUP LIMITEDNQ626.OPT2017-09-06