FDA.reportPublic FDA data

Kappa/lambda light chain immunoglobulin IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen.
GUDID devices
35
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00817089023512DiazymeDIAZYME LABORATORIES, INC.06U95102025-10-22
B502BSB9250CS0Kappa Light Chains Control SlidesBIO SB, INC.BSB-9250-CS2025-03-18
B502BSB9254CS0Lambda Control SlidesBIO SB, INC.BSB-9254-CS2025-03-18
B502BSB36880Kappa control slidesBIO SB, INC.Control Slides,52020-06-30
05051700016803Freelite® Kappa AMR Check Fluid SDTHE BINDING SITE GROUP LIMITEDBP538.SD2023-08-09
05051700016810Freelite® Lambda AMR Check Fluid SDTHE BINDING SITE GROUP LIMITEDBP539.SD2023-08-09
05051700002059Freelite® Panel Sample SetTHE BINDING SITE GROUP LIMITEDBP2282023-06-29
03607360051122FLC Control Level 1SEBIA51122023-03-31
03607360051139FLC Control Level 2SEBIA51132023-03-31
B502BSB3009CS0Kappa / FITC control slidesBIO SB, INC.control slides, 52020-09-30
B502BSB3010CS0Lambda / FITC control slidesBIO SB, INC.control slides, 52020-09-30
B502BSB57070Kappa Light Chains Control SlidesBIO SB, INC.Control Slides, 5 2020-08-31
B502BSB57210Lambda Control SlidesBIO SB, INC.Control Slides, 5 2020-08-31
00817089023024DiazymeDIAZYME LABORATORIES, INC.088965771902020-07-21
00817089021716DiazymeDIAZYME LABORATORIES, INC.DZ169A-CON2020-07-16
L502BSB3688Kappa control slidesBIO SB, INC.Control Slides,52020-06-30
B502BSB36890Lambda Control SlidesBIO SB, INC.Control Slides, 52020-06-15
05051700018654Freelite® Human Lambda Free Control Pack for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDNQ018.T2017-06-05
05051700018661Freelite® Human Kappa Free Control Pack for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDNQ016.T2017-06-05
05051700018715 Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™THE BINDING SITE GROUP LIMITEDNQ018.IM2017-06-05
05051700018722Freelite® Human Kappa Free Control Pack for use on the SPAPLUS®THE BINDING SITE GROUP LIMITEDNQ016.S2017-06-05
05051700018739 Freelite® Human Kappa Free Control Pack For use on the Beckman Coulter IMMAGE™/THE BINDING SITE GROUP LIMITEDNQ016.IM2017-06-05
05051700018746Freelite® Human Lambda Free Control Pack for use on the SPAPLUS® THE BINDING SITE GROUP LIMITEDNQ018.S2017-06-05
05051700018753Optilite® Freelite® Lambda Free Control PackTHE BINDING SITE GROUP LIMITEDNQ018.OPT 2017-06-05
05051700018760Optilite® Freelite® Kappa Free Control PackTHE BINDING SITE GROUP LIMITEDNQ016.OPT2017-06-05
05051700018777Freelite® Human Lambda Free Control Pack For use on the Roche Cobas Integra®THE BINDING SITE GROUP LIMITEDNQ018.RI2017-06-05
05051700018784Freelite® Human Kappa Free Control Pack For use on the Roche Cobas Integra®THE BINDING SITE GROUP LIMITEDNQ016.RI2017-06-05
05051700018838 Freelite® Human Kappa Free Control Pack For use on the Roche Cobas™ c SystemsTHE BINDING SITE GROUP LIMITEDNQ016.CB2017-06-05
05051700018845 Freelite® Human Lambda Free Control Pack For use on the Roche Cobas™ c SystemsTHE BINDING SITE GROUP LIMITEDNQ018.CB2017-06-05
05051700020169Freelite Kappa Free Panel Sample SetTHE BINDING SITE GROUP LIMITEDBP2332017-12-19
05051700020176Freelite Lambda Free Panel Sample SetTHE BINDING SITE GROUP LIMITEDBP2342017-12-19
00842768031458N FLC Control SL1Siemens Healthcare Diagnostics Products GmbH104824412018-02-20
00842768031465N FLC Control SL2Siemens Healthcare Diagnostics Products GmbH104824422018-02-20
00630414237480N FLC CONTROL SL1Siemens Healthcare Diagnostics Products GmbH108736612018-10-08
00630414237503N FLC CONTROL SL2Siemens Healthcare Diagnostics Products GmbH108736632018-10-08