FDA.reportPublic FDA data

Negative control immunoglobulin IVD

Definition
A material containing immunoglobulin intended to be used in place of a primary antibody as a negative control to verify the performance of an assay that utilizes antibodies (e.g., immunoassay, immunohistochemistry or flow cytometry) and is performed on biological tissues or clinical specimens.
GUDID devices
48
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05055331335425BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0777-U2022-12-16
05055331335555BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0996-U2022-12-16
10190302009492Mouse IgM Purified AntibodyLIFE TECHNOLOGIES CORPORATIONMGM002018-07-02
10190302009508Mouse IgM FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMGM012018-07-02
10190302009515Mouse IgM R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONMGM042018-07-02
05700575005251MMR Negative Control Reagent, Mouse (Dako Omnis)AGILENT TECHNOLOGIES, INC.GE1012025-08-27
05700575005268MMR Negative Control Reagent, Rabbit (Dako Omnis)AGILENT TECHNOLOGIES, INC.GE1022025-08-27
00850041090917MULTICHEMLgc Clinical Diagnostics, Inc.2010-02602025-05-15
00850041090078ACCURUN®Lgc Clinical Diagnostics, Inc.2010-00252024-08-02
00850041090085ACCURUN®Lgc Clinical Diagnostics, Inc.2010-00262024-08-02
04015630984732Rabbit Monoclonal Negative Control IgVentana Medical Systems, Inc.066833800012022-12-07
10634853000169Fungal SerologyMICROBIOLOGICS INC.2001552022-09-26
05055331303707BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA09962021-05-07
05055331303837BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA07772021-05-07
00884883007772MAS SARS-CoV-2 Negative ControlMicrogenics Corporation100283062021-03-05
04015630971138PROTEASE 1Ventana Medical Systems, Inc.052666880012021-01-29
04015630971145PROTEASE 2Ventana Medical Systems, Inc.052666960012021-01-29
04015630971152PROTEASE 3Ventana Medical Systems, Inc.052667180012021-01-29
04015630971169HEMATOXYLINVentana Medical Systems, Inc.052667260012021-01-29
04015630971947CONFIRM Negative Control Rabbit Ig AntibodyVentana Medical Systems, Inc.052662380012021-01-29
05700571101766FLEX Negative Control Rb Immunoglobulin RTU (Link)AGILENT TECHNOLOGIES, INC.IR6002020-09-17
05700571101773FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3, IgM RTU (Link)AGILENT TECHNOLOGIES, INC.IR7502020-09-17
05700571101902FLEX Negative Control Rb Immunoglobulin RTUAGILENT TECHNOLOGIES, INC.IS6002020-09-17
05700571101919FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3 and IgM RTUAGILENT TECHNOLOGIES, INC.IS7502020-09-17
05700571106723FLEX Universal Negative Control Mo RTU (Dako Omnis)AGILENT TECHNOLOGIES, INC.GA7502020-09-17
05700571106730FLEX Universal Negative Control Rb RTU (Dako Omnis)AGILENT TECHNOLOGIES, INC.GA6002020-09-17
00615233002891Genemed®SAKURA FINETEK U.S.A., INC.10-00012019-12-28
00615233006561Genemed®SAKURA FINETEK U.S.A., INC.60-0045-72019-12-28
00615233002358Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8604-C0102020-01-01
00615233002365Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8605-C0102020-01-01
00615233008008Tissue-Tek Genie® DUOSAKURA FINETEK U.S.A., INC.8482-C0102020-01-01
00615233008015Tissue-Tek Genie® DUOSAKURA FINETEK U.S.A., INC.8482-M2502020-01-01
00615233008022Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8604-M2502020-01-01
00615233008039Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8605-M2502020-01-01
00382903391967N/ABecton, Dickinson And Company3391962018-11-28
00382903407545N/ABecton, Dickinson And Company3407542018-11-28
00382903407552N/ABecton, Dickinson And Company3407552018-11-28
00382903407569N/ABecton, Dickinson And Company3407562018-11-28
00382903407576N/ABecton, Dickinson And Company3407572018-11-28
00382903407606N/ABecton, Dickinson And Company3407602018-11-28
00382903407613N/ABecton, Dickinson And Company3407612018-11-28
00382903407620N/ABecton, Dickinson And Company3407622018-11-28
00382903407644N/ABecton, Dickinson And Company3407642018-11-28
00382903407651N/ABecton, Dickinson And Company3407652018-11-28
00382903407668N/ABecton, Dickinson And Company3407662018-11-28
00382903487981N/ABecton, Dickinson And Company3487982018-11-28
00382903488025N/ABecton, Dickinson And Company3488022018-11-28
00382906414106N/ABecton, Dickinson And Company6414102018-11-28