FDA.reportPublic FDA data

Kappa/lambda light chain immunoglobulin IVD, antibody

Definition
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of kappa and/or lambda light chain immunoglobulins in a clinical specimen.
GUDID devices
206
Last updated
2026-06-16 06:05:33

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405004003Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob5442026-06-05
00846405004010Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob544-052026-06-05
00846405004027Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob544-012026-06-05
00846405004638Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob0772026-06-05
00846405004645Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob077-052026-06-05
00846405004652Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob077-012026-06-05
00846405006939Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM0552026-06-05
00846405007097Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM0562026-06-05
00846405007653Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR0152026-06-05
00846405007677Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR0162026-06-05
00846405011735Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP0252026-06-05
00846405011742Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP025-052026-06-05
00846405011759Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP025-012026-06-05
00846405011797Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP0272026-06-05
00846405011803Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP027-052026-06-05
00846405011810Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP027-012026-06-05
00846405012732Diagnostic BioSystemsDiagnostic Biosystems, Inc.FLC2132026-06-05
00846405012749Diagnostic BioSystemsDiagnostic Biosystems, Inc.FLC213-012026-06-05
00846405012756Diagnostic BioSystemsDiagnostic Biosystems, Inc.FLC2142026-06-05
00846405012763Diagnostic BioSystemsDiagnostic Biosystems, Inc.FLC214-012026-06-05
00846405013081Diagnostic BioSystemsDiagnostic Biosystems, Inc.F0012026-06-05
00846405013098Diagnostic BioSystemsDiagnostic Biosystems, Inc.F0022026-06-05
00846405014002Diagnostic BioSystemsDiagnostic Biosystems, Inc.F001-012026-06-05
00846405014019Diagnostic BioSystemsDiagnostic Biosystems, Inc.F002-012026-06-05
00846405017027Diagnostic BioSystemsDiagnostic Biosystems, Inc.F001-MS2026-06-05
00846405017034Diagnostic BioSystemsDiagnostic Biosystems, Inc.F002-MS2026-06-05
00846405017430Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM056-HL2026-06-05
00846405018093Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM055-HL2026-06-05
00846405019694Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM055-10MM2026-06-05
00846405021970Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM055-S2026-06-05
00846405021987Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR015-S2026-06-05
00846405022014Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM056-S2026-06-05
00846405022021Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR016-S2026-06-05
00846405024858Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM056-252026-06-05
00847627041821Lambda Light Chain [N10/2]BIOCARE MEDICAL LLCNPAI3063T40 2025-10-21
10190302009522Human Kappa FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMH105112018-04-10
10190302009539Human Kappa R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONMH105142018-04-10
10190302009546Human Kappa APC ConjugateLIFE TECHNOLOGIES CORPORATIONMH105152018-04-10
10190302009553Human Kappa Alexa Fluor® 488 ConjugateLIFE TECHNOLOGIES CORPORATIONMH105202018-04-10
10190302009560Human Lambda FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMH106112018-04-10
10190302009577Human Lambda R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONMH106142018-04-10
M52592570Antiserum to Human Lambda Light ChainHELENA LABORATORIES CORPORATION92572016-09-07
M52592620Antiserum to Human Kappa Light ChainHELENA LABORATORIES CORPORATION92622016-09-07
M52594120IFE Free Kappa Light Chain AntiserumHELENA LABORATORIES CORPORATION94122016-09-07
M52594130IFE Free Lambda Light Chain AntiserumHELENA LABORATORIES CORPORATION94132016-09-07
M52594230IFE Free Lambda Light Chain AntiserumHELENA LABORATORIES CORPORATION94232024-09-27
00810170553479IHCSlmp, LLC(BTO) Sample Kappa Light Chain Antibody (2ml)2025-03-14
00810170552106IHCSlmp, LLC(BTO) RTU Kappa Light Chain Antibody (10ml)2025-03-06
00810170550072IHCSlmp, LLC(BTO) Kappa Light Chain Antibody with FITC Tag2025-03-03
00810170550089IHCSlmp, LLC(BTO) Lambda Light Chain Antibody with FITC Tag2025-03-03
B502BSB57180Lambda MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB57190Lambda MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB57200Lambda MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
B502BSB300910Kappa / FITC GPabBIO SB, INC.Concentrate, 1 ml2020-03-16
B502BSB301010Lambda / FITC GPabBIO SB, INC.Concentrate, 1 ml2020-03-16
B502BSB57030Tinto Kappa Light ChainsBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB57040Kappa Light Chains MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB57050Kappa Light Chains MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB57060Kappa Light Chains MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
M52594220IFE Free Kappa Light Chain AntiserumHELENA LABORATORIES CORPORATION94222024-09-27
00847627034939Kappa (M) + Lambda (P)BIOCARE MEDICAL LLCOPAI3159DST602024-08-20
05055331333896NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDKAP-581-L-U2023-07-28
05055331333919NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDLAM-578-L-U2023-07-28
05055331335296BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0570-U2023-07-28
05055331335319BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0606-U2023-07-28
00810113062112Rabbit Polyclonal Anti-Human Lambda Light Chain (Polyclonal) AntibodyEpitomics Inc.AC-0068B2023-06-12
00810113062129Rabbit Polyclonal Anti-Human Lambda Light Chain (Polyclonal) AntibodyEpitomics Inc.AC-0068A2023-06-12
00810113062136Rabbit Polyclonal Anti-Human Lambda Light Chain (Polyclonal) AntibodyEpitomics Inc.AC-00682023-06-12
00810113062143Rabbit Polyclonal Anti-Human Lambda Light Chain (Polyclonal) AntibodyEpitomics Inc.AC-0068BULK2023-06-12
00810113062150Rabbit Polyclonal Anti-Human Kappa Light Chain (Polyclonal) AntibodyEpitomics Inc.AC-0069A2023-06-12
00810113062167Rabbit Polyclonal Anti-Human Kappa Light Chain (Polyclonal) AntibodyEpitomics Inc.AC-0069B2023-06-12
00810113062174Rabbit Polyclonal Anti-Human Kappa Light Chain (Polyclonal) AntibodyEpitomics Inc.AC-00692023-06-12
00810113062181Rabbit Polyclonal Anti-Human Kappa Light Chain (Polyclonal) AntibodyEpitomics Inc.AC-0069BULK2023-06-12
00810113063911Rabbit Monoclonal Anti-Human Kappa Light Chain Antibody, EP171Epitomics Inc.AC-0149BULK2023-06-09
00810113063928Rabbit Monoclonal Anti-Human Kappa Light Chain Antibody, EP171Epitomics Inc.AC-0149B2023-06-09
00810113063935Rabbit Monoclonal Anti-Human Kappa Light Chain Antibody, EP171Epitomics Inc.AC-0149A2023-06-09
00810113063942Rabbit Monoclonal Anti-Human Kappa Light Chain Antibody, EP171Epitomics Inc.AC-01492023-06-09
00810113063966Rabbit Monoclonal Anti-Human Lambda Light Chain Antibody, EP172Epitomics Inc.AC-0150BULK2023-06-09
00810113063973Rabbit Monoclonal Anti-Human Lambda Light Chain Antibody, EP172Epitomics Inc.AC-0150A2023-06-09
00810113063980Rabbit Monoclonal Anti-Human Lambda Light Chain Antibody, EP172Epitomics Inc.AC-0150B2023-06-09