Method, Nephelometric, Immunoglobulins (G, A, M)

FDA product code CFN · 58 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5510
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-07-21 – 2023-12-13

CFN 2023-12-13

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K233663

View details →

CFN 2023-08-02

Immunoglobulin G (IgG)

Applicant Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

K number K221114

View details →

CFN 2019-09-04

Human IgA liquid reagent kit for Use on SPAPlus

Applicant The Binding Site Group , Ltd.

K number K192116

View details →

CFN 2019-08-19

Optilite IgA Kit

Applicant The Binding Site Group , Ltd.

K number K191985

View details →

CFN 2019-07-15

Optilite IgM Kit

Applicant The Binding Site Group , Ltd.

K number K191635

View details →

CFN 2019-06-27

Human IgM Kit for use on SPAPlus

Applicant The Binding Site Group , Ltd.

K number K191465

View details →

CFN 2019-05-28

Optilite IgM CSF Kit

Applicant The Binding Site Group , Ltd.

K number K190686

View details →

CFN 2019-01-23

Optilite IgA CSF Kit

Applicant The Binding Site Group , Ltd.

K number K183151

View details →

CFN 2017-01-09

DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent

Applicant Beckman Coulter, Inc.

K number K162208

View details →

CFN 2013-05-30

HUMAN IGA CSF KIT FOR USE ON SPAPLUS

Applicant The Binding Site Group , Ltd.

K number K120901

View details →

CFN 2013-05-17

HUMAN IGM CSF KIT

Applicant The Binding Site Group , Ltd.

K number K120750

View details →

CFN 2013-05-17

HUMAN IGG CSF KIT

Applicant The Binding Site Group , Ltd.

K number K120749

View details →

CFN 2013-03-27

HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT

Applicant The Binding Site Group , Ltd.

K number K113823

View details →

CFN 2012-02-27

HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS

Applicant The Binding Site

K number K103824

View details →

CFN 2010-08-16

HUMAN IGA2 KIT FOR USE ON THE SPAPLUS

Applicant The Binding Site Group , Ltd.

K number K100588

View details →

CFN 2010-03-01

HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS

Applicant The Binding Site Group , Ltd.

K number K082823

View details →

CFN 2009-12-30

HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)

Applicant The Binding Site, Ltd.

K number K090920

View details →

CFN 2009-04-29

DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID

Applicant Siemens Healthcare Diagnostics

K number K090594

View details →

CFN 2009-03-24

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

Applicant Siemens Healthcare Diagnostics

K number K083445

View details →

CFN 2009-02-10

HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER

Applicant The Binding Site, Ltd.

K number K082129

View details →

CFN 2008-12-19

HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS

Applicant The Binding Site, Ltd.

K number K081827

View details →

CFN 2008-07-28

DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

Applicant Dade Behring, Inc.

K number K081161

View details →

CFN 2008-02-26

DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR

Applicant Dade Behring, Inc.

K number K073561

View details →

CFN 2008-02-11

OLYMPUS IGG REAGENT

Applicant Olympus America, Inc.

K number K073490

View details →

CFN 2008-02-11

OLYMPUS IGA REAGENT

Applicant Olympus America, Inc.

K number K073489

View details →

CFN 2008-02-11

OLYMPUS IGM REAGENT

Applicant Olympus America, Inc.

K number K073487

View details →

CFN 2008-02-01

HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER

Applicant The Binding Site, Ltd.

K number K072889

View details →

CFN 2006-08-24

DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H

Applicant Dade Behring, Inc.

K number K061845

View details →

CFN 2006-07-06

DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY

Applicant Dade Behring, Inc.

K number K061338

View details →

CFN 2005-02-15

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)

Applicant Dade Behring, Inc.

K number K042735

View details →

CFN 2004-11-22

BINDING SITE IGG SUBLCASS OLYMPUS KITS

Applicant The Binding Site

K number K042152

View details →

CFN 2004-11-10

VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC

Applicant Ortho-Clinical Diagnostics, Inc.

K number K042475

View details →

CFN 2003-08-07

N LATEX IGM

Applicant Dade Behring, Inc.

K number K032014

View details →

CFN 2002-07-16

HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER

Applicant The Binding Site, Ltd.

K number K022083

View details →

CFN 2001-08-31

HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T

Applicant The Binding Site, Ltd.

K number K012296

View details →

CFN 2001-08-31

HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB

Applicant The Binding Site, Ltd.

K number K012292

View details →

CFN 2001-08-20

HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T

Applicant The Binding Site, Ltd.

K number K012295

View details →

CFN 2001-08-20

HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA

Applicant The Binding Site, Ltd.

K number K012291

View details →

CFN 2000-04-27

HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER

Applicant The Binding Site, Ltd.

K number K000701

View details →

CFN 2000-02-01

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR

Applicant Beckman Coulter, Inc.

K number K993549

View details →

CFN 2000-02-01

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB

Applicant Beckman Coulter, Inc.

K number K993547

View details →

CFN 2000-01-14

WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD

Applicant Wako Chemicals USA, Inc.

K number K993924

View details →

CFN 1999-12-21

IGM MININEPH ANTISERUM

Applicant The Binding Site, Ltd.

K number K981784

View details →

CFN 1999-12-20

IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS

Applicant The Binding Site, Ltd.

K number K982100

View details →

CFN 1998-12-04

HUMAN IGA SUBCLASS BNII COMBI KIT

Applicant The Binding Site, Ltd.

K number K981912

View details →

CFN 1998-09-28

COBAS INTEGRA REAGENT CASSETTES

Applicant Roche Diagnostic Systems, Inc.

K number K982382

View details →

CFN 1994-03-22

N-ASSAY TIA IGA

Applicant Crestat Diagnostics, Inc.

K number K933971

View details →

CFN 1994-03-22

N-ASSAY TIA IGM

Applicant Crestat Diagnostics, Inc.

K number K933970

View details →

CFN 1994-01-28

N-ASSAY TIA MULTI V-NL

Applicant Crestat Diagnostics, Inc.

K number K933973

View details →

CFN 1992-08-20

WAKO IGG-HA

Applicant Wako Chemicals USA, Inc.

K number K923070

View details →

CFN 1988-04-07

N PROTEIN STANDARD PLASMA (HUMAN)

Applicant Behring Diagnostics, Inc.

K number K880356

View details →

CFN 1987-05-15

QM2/QM300 BUFFER AND DILUENT PACK

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

K number K871343

View details →

CFN 1986-12-01

MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX

Applicant Eiken Chemical Co., Inc.

K number K864342

View details →

CFN 1986-04-15

BEHRING NEPHELOMETER SYSTEM

Applicant Behring Diagnostics, Inc.

K number K860894

View details →

CFN 1978-11-08

NEPHELRATE ANTISERUMS, IGG

Applicant Antibodies, Inc.

K number K781656

View details →

CFN 1978-11-08

NEPHELRATE ANTISERUMS 1GA

Applicant Antibodies, Inc.

K number K781655

View details →

CFN 1978-11-08

NEPHELRATE ANTIPERUMS LGM

Applicant Antibodies, Inc.

K number K781654

View details →

CFN 1977-07-21

LAS-R TEST PROGRAM

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K771226

View details →