FDA.reportPublic FDA data

Total immunoglobulin E (IgE 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 E (IgE total) in a clinical specimen.
GUDID devices
10
Last updated
2025-03-05 15:16:59

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B502BSB30730IgE control slidesBIO SB, INC.Control Slides, 52020-06-30
B502BSB3011CS0IgE / FITC control slidesBIO SB, INC.control slides, 52020-09-30
00630414126265ADVIA Centaur® IgE MCMSiemens Healthcare Diagnostics Inc.103116212020-09-24
00630414599403Atellica IM tIgE MCMSiemens Healthcare Diagnostics Inc.109956172020-09-24
00630414973692IMMULITE® Systems TIE Calibration Verification Material Total IgESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103880012020-09-24
L502BSB3073IgE control slidesBIO SB, INC.Control Slides, 52020-06-30
00816426021372K-ASSAY® Total IgE ControlKAMIYA BIOMEDICAL COMPANY, LLCK94C-2M2019-01-25
00816426021389K-ASSAY® Total IgE ControlKAMIYA BIOMEDICAL COMPANY, LLCK94C-4M2019-01-25
00816879022285Hytec Specific/Total IgE ControlHYCOR BIOMEDICAL LLC741202016-09-26
00630414953458IMMULITE® Systems TIE CONTROL Total IgESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103853492016-09-24