DBF · Class II · 21 CFR 866.5340

FDA Product Code DBF: Ferritin, Antigen, Antiserum, Control

Leading manufacturers include Amersham Corp., Diagnostic Products Corp. and Abbott Laboratories.

87
Total
87
Cleared
67d
Avg days
1977
Since
87 devices
25–48 of 87
Cleared Aug 05, 1993
VISTA FERRITIN ASSAY
K931576
Syva Co.
Immunology · 128d
Cleared Dec 15, 1992
AIA-PACK FER CALIBRATION VERIFICATION TEST SET
K924858
Tosoh Medics, Inc.
Immunology · 78d
Cleared Apr 07, 1992
VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
K920952
Vitek Systems, Inc.
Immunology · 41d
Cleared Jan 28, 1992
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
K920046
Medix Biotech, Inc.
Immunology · 22d
Cleared Mar 12, 1991
CIBA CORNING ACS FERRITIN IMMUNOASSAY
K905770
Ciba Corning Diagnostics Corp.
Immunology · 75d
Cleared Dec 04, 1989
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
K896585
Medix Biotech, Inc.
Immunology · 13d
Cleared Oct 17, 1989
LAN.0800Q/2800Q
K895872
Amersham Corp.
Immunology · 13d
Cleared May 09, 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362
Amersham Corp.
Immunology · 33d
Cleared Jan 04, 1989
AFFINITY(TM) FERRITIN IMMUNIT(TM)
K885074
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 27d
Cleared Jan 27, 1988
AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800
K874203
Amersham Corp.
Immunology · 104d
Cleared Dec 02, 1987
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
K874572
Nichols Institute Diagnostics
Immunology · 27d
Cleared Nov 25, 1987
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
K874031
Diagnostic Products Corp.
Immunology · 54d
Cleared Oct 07, 1987
CIBA CORNING MAGIC LITE FERRITIN
K873573
Ciba Corning Diagnostics Corp.
Immunology · 35d
Cleared Jun 12, 1987
DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM
K871489
Diagnostic Systems Laboratories, Inc.
Immunology · 58d
Cleared Mar 12, 1987
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM
K870570
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 30d
Cleared Feb 10, 1987
COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS
K870107
Diagnostic Products Corp.
Immunology · 29d
Cleared Jan 16, 1987
BECKMAN EPSILON(TM) FERRITIN TEST KIT
K864437
Beckman Instruments, Inc.
Immunology · 65d
Cleared Oct 08, 1986
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
K863345
Hybritech, Inc.
Immunology · 40d
Cleared Oct 01, 1986
QUANTIMUNE(R) FERRITIN IRMA
K863487
Bio-Rad
Immunology · 22d
Cleared Jun 19, 1986
IMMPULSE FERRITIN ASSAY REAGENT
K862014
Sclavo, Inc.
Chemistry · 22d
Cleared Mar 28, 1986
ENZYMUN-TEST FERRITIN
K860137
Boehringer Mannheim Corp.
Immunology · 73d
Cleared Nov 19, 1984
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K844158
American Dade
Immunology · 26d
Cleared May 25, 1984
DSL FERRITIN IRMA
K841925
Diagnostic Systems Laboratories, Inc.
Immunology · 15d
Cleared Mar 24, 1983
CORNING FERRITIN 125I RADIOIMMUNOASSAY
K830591
Corning Medical & Scientific
Chemistry · 28d