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Kappa, Antigen, Antiserum, Control

FDA product code DFH · 62 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5550
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-07-27 – 2025-12-19

DFH 2025-12-19

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay

Applicant Diazyme Laboratories, Inc.

K number K253358

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DFH 2025-05-23

Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit

Applicant The Binding Site Group , Ltd.

K number K250549

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DFH 2024-02-23

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

Applicant Sebia

K number K231601

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DFH 2024-01-24

Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit

Applicant The Binding Site, Ltd.

K number K231290

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DFH 2022-11-18

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

Applicant Sebia

K number K210623

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DFH 2022-09-08

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

Applicant Diazyme Laboratories, Inc.

K number K211648

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DFH 2022-08-04

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

Applicant Diazyme Laboratories, Inc.

K number K220001

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DFH 2022-03-02

N Latex FLC kappa, N Latex FLC lambda

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K212379

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DFH 2021-10-29

N Latex FLC kappa, N Latex FLC lambda

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K201496

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DFH 2021-07-14

N Latex FLC kappa, N Latex FLC lambda

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K193047

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DFH 2019-05-03

N Latex FLC kappa, N Latex FLC lambda

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K190879

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DFH 2018-11-01

N Latex FLC kappa assay, N Latex FLC lambda assay

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K182098

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DFH 2018-08-23

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit

Applicant The Binding Site Group , Ltd.

K number K173732

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DFH 2018-06-26

Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay

Applicant Diazyme Laboratories, Inc.

K number K181438

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DFH 2017-11-17

N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K171742

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DFH 2016-11-18

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator

Applicant Diazyme Laboratories

K number K153394

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DFH 2013-04-01

HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER

Applicant The Binding Site Group , Ltd.

K number K120056

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DFH 2009-09-03

KAPPA LIGHT CHAINS

Applicant SENTINEL CH. SpA

K number K083602

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DFH 2008-12-19

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

Applicant Siemens Healthcare Diagnostics

K number K082503

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DFH 2007-11-30

FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT

Applicant The Binding Site, Ltd.

K number K070900

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DFH 2007-06-21

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER

Applicant The Binding Site, Ltd.

K number K062372

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DFH 2005-09-06

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER

Applicant The Binding Site, Ltd.

K number K051915

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DFH 2005-06-27

CAPILLARY'S IMMUNOTYPING (PN 2100)

Applicant Sebia, Inc.

K number K042939

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DFH 2004-03-11

FREELITE HUMAN KAPPA AND LAMBDA KITS

Applicant The Binding Site, Ltd.

K number K040009

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DFH 2003-01-21

FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER

Applicant The Binding Site, Ltd.

K number K023009

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DFH 2001-02-01

KAPPA IMMAGE FREELITE KIT

Applicant The Binding Site, Ltd.

K number K003669

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DFH 2000-10-26

SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT

Applicant The Binding Site, Ltd.

K number K002564

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DFH 1997-02-10

IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG

Applicant Beckman Instruments, Inc.

K number K964260

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DFH 1995-10-27

CHEMMATE(TM) UCHL1 (CD45-RO)

Applicant Biotek Solutions, Inc.

K number K950152

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DFH 1995-10-27

CHEMMATE(TM) KAPPA

Applicant Biotek Solutions, Inc.

K number K950150

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DFH 1990-06-21

BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)

Applicant Beckman Instruments, Inc.

K number K902484

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DFH 1988-12-06

BECKMAN LAMBDA LIGHT CHAIN REAGENT

Applicant Beckman Instruments, Inc.

K number K884597

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DFH 1988-11-16

BECKMAN KAPPA LIGHT CHAIN REAGENT

Applicant Beckman Instruments, Inc.

K number K884276

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DFH 1988-02-17

N-IMMUNOGLOBULIN LIGHT CHAIN KIT

Applicant Behring Diagnostics, Inc.

K number K880341

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DFH 1988-01-22

QM300 KAPPA LIGHT CHAINS ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K875164

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DFH 1986-02-26

QUANTIMETRIC PLUS KAPPA REAGENT KIT

Applicant Kallestad Laboratories, Inc.

K number K855008

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DFH 1984-08-28

TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM

Applicant Miles Laboratories, Inc.

K number K842470

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DFH 1984-08-02

AMER. HISTO-ID SYS PRIMARY KIT

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K842326

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DFH 1983-10-31

FITC GOAT ANTI-HUMAN KAPPA AFFINITY

Applicant Gelco Diagnostics, Inc.

K number K832266

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DFH 1983-10-31

GOAT ANTI-HUMAN IMMUNOGLOBULINS-

Applicant Gelco Diagnostics, Inc.

K number K832256

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DFH 1982-11-17

RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA

Applicant Amico Lab, Inc.

K number K823121

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DFH 1982-11-17

FITC ANTISERA TO HUMAN C3

Applicant Amico Lab, Inc.

K number K822679

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DFH 1982-11-17

FITC ANTISERA TO HUMAN GOBULIN

Applicant Amico Lab, Inc.

K number K822678

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DFH 1982-11-17

FITC ANTISERA TO HUMAN IGM

Applicant Amico Lab, Inc.

K number K822677

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DFH 1982-11-17

FITC ANTISERA TO HUMAN IGG

Applicant Amico Lab, Inc.

K number K822676

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DFH 1982-11-17

FITC ANTISERA TO HUMAN IGA

Applicant Amico Lab, Inc.

K number K822675

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DFH 1982-11-17

FITC ANTISERA TO HUMAN LAMBDA

Applicant Amico Lab, Inc.

K number K822674

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DFH 1982-11-17

FITC ANTISERA TO HUMAN KAPPA

Applicant Amico Lab, Inc.

K number K822673

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DFH 1982-11-17

ANTISERUM TO HUMAN GOBULIN

Applicant Amico Lab, Inc.

K number K822671

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DFH 1982-11-17

ANTISERUM TO HUMAN IGM

Applicant Amico Lab, Inc.

K number K822670

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DFH 1982-11-17

ANTISERUM TO HUMAN IGG

Applicant Amico Lab, Inc.

K number K822669

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DFH 1982-11-17

ANTISERUM TO HUMAN IGA

Applicant Amico Lab, Inc.

K number K822668

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DFH 1982-11-17

ANTISERUM TO HUMAN LAMBDA

Applicant Amico Lab, Inc.

K number K822667

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DFH 1982-11-17

ANTISERUM TO HUMAN KAPPA

Applicant Amico Lab, Inc.

K number K822666

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DFH 1982-02-10

DAKO PAP KIT K504

Applicant Dako Corp.

K number K812485

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DFH 1981-09-29

IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA

Applicant Dako Corp.

K number K812661

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DFH 1981-07-16

H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME

Applicant Immulok, Inc.

K number K811721

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DFH 1980-10-23

ANTISERA TO HUMAN FREE KAPPA CHAINS

Applicant Kallestad Laboratories, Inc.

K number K802283

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DFH 1979-11-27

ANTI-HUMAN KAPPA SERUM

Applicant Diagnostica, Inc.

K number K791284

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DFH 1979-09-12

ANTISERUM TO RABBIT IGG H & L CHAIN

Applicant Kent Laboratories, Inc.

K number K790706

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DFH 1978-07-27

KAPPA SERUM (FREE & BOUND) ANTI-HUMAN

Applicant Icl Scientific

K number K781028

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DFH 1978-07-27

KAPPA SERUM (FREE) ANTI-HUMAN

Applicant Icl Scientific

K number K781027

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