FDA.report

Insulin IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of insulin in a clinical specimen.
GUDID devices
15
Last updated
2025-03-04 15:09:24

Related Product Codes

CodeDeviceSpecialtyClassDevices
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry18
LJGQuality Control SlidesMicrobiology12
CFPRadioimmunoassay, Immunoreactive InsulinClinical Chemistry11
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry11
OHQMulti-Analyte Controls UnassayedClinical Chemistry11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
B502BSB57000Insulin control slidesBIO SB, INC.Control Slides, 5 2020-06-01
B502BSB68410Insulin control slidesBIO SB, INC.Control Slides, 5 2020-06-01
00850011135273ValidateMAINE STANDARDS COMPANY, LLC204ro2020-12-14
00630414461007ADVIA Centaur® IRI MCMSiemens Healthcare Diagnostics Inc.103104372020-09-24
00630414600482Atellica IM IRI MCMSiemens Healthcare Diagnostics Inc.109956322020-09-24
00630414973708IMMULITE® Systems INS Calibration Verification Material InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103880052020-09-24
00630414998954IMMULITE® INS Control InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD102866142020-09-24
00380740169817ARCHITECTAbbott GmbH & Co. KG08K41122019-11-22
07350108630078Diabetes Antigen Control (Unassayed)Mercodia AB10-1134-012020-04-08
B085K909M50Audit MicroControls Linearity FD Special Diabetes AALTO SCIENTIFICK909M-52019-02-14
00816426021358K-ASSAY® Insulin ControlKAMIYA BIOMEDICAL COMPANY, LLCK73C-2M2019-01-25
00816426021365K-ASSAY® Insulin ControlKAMIYA BIOMEDICAL COMPANY, LLCK73C-4M2019-01-25
00817089020757DiazymeDIAZYME LABORATORIES, INC.DZ865A-CON2016-11-03
00380740017545ARCHITECTABBOTT LABORATORIES8K41-112016-06-06
00380740150808AlinityAbbott GmbH & Co. KG04T75102018-12-04