CFN · Class II · 21 CFR 866.5510

FDA Product Code CFN: Method, Nephelometric, Immunoglobulins (g, A, M)

Leading manufacturers include The Binding Site Group , Ltd., The Binding Site, Ltd. and Dade Behring, Inc..

61
Total
61
Cleared
146d
Avg days
1977
Since
61 devices
25–48 of 61
Cleared Jul 28, 2008
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
K081161
Dade Behring, Inc.
Immunology · 95d
Cleared Feb 26, 2008
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
K073561
Dade Behring, Inc.
Immunology · 69d
Cleared Feb 11, 2008
OLYMPUS IGM REAGENT
K073487
Olympus America, Inc.
Immunology · 61d
Cleared Feb 11, 2008
OLYMPUS IGA REAGENT
K073489
Olympus America, Inc.
Immunology · 61d
Cleared Feb 11, 2008
OLYMPUS IGG REAGENT
K073490
Olympus America, Inc.
Immunology · 61d
Cleared Feb 01, 2008
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
K072889
The Binding Site, Ltd.
Immunology · 114d
Cleared Aug 24, 2006
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
K061845
Dade Behring, Inc.
Immunology · 56d
Cleared Jul 06, 2006
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
K061338
Dade Behring, Inc.
Immunology · 52d
Cleared Feb 15, 2005
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
K042735
Dade Behring, Inc.
Immunology · 137d
Cleared Nov 22, 2004
BINDING SITE IGG SUBLCASS OLYMPUS KITS
K042152
The Binding Site
Immunology · 105d
Cleared Nov 10, 2004
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS
K042475
Ortho-Clinical Diagnostics, Inc.
Immunology · 58d
Cleared Aug 07, 2003
N LATEX IGM
K032014
Dade Behring, Inc.
Immunology · 38d
Cleared Jul 16, 2002
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
K022083
The Binding Site, Ltd.
Immunology · 20d
Cleared Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
K012292
The Binding Site, Ltd.
Immunology · 42d
Cleared Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
K012296
The Binding Site, Ltd.
Immunology · 42d
Cleared Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
K012291
The Binding Site, Ltd.
Immunology · 31d
Cleared Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
K012295
The Binding Site, Ltd.
Immunology · 31d
Cleared Apr 27, 2000
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
K000701
The Binding Site, Ltd.
Immunology · 57d
Cleared Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
K993547
Beckman Coulter, Inc.
Immunology · 105d
Cleared Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
K993549
Beckman Coulter, Inc.
Immunology · 105d
Cleared Jan 14, 2000
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993924
Wako Chemicals USA, Inc.
Immunology · 57d
Cleared Dec 21, 1999
IGM MININEPH ANTISERUM
K981784
The Binding Site, Ltd.
Immunology · 580d
Cleared Dec 20, 1999
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
K982100
The Binding Site, Ltd.
Immunology · 553d
Cleared Dec 04, 1998
HUMAN IGA SUBCLASS BNII COMBI KIT
K981912
The Binding Site, Ltd.
Immunology · 186d