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 Feb 17, 1998
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
K974505
Alfa Biotech (Uk) , Ltd.
Immunology · 78d
Cleared Oct 22, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
K973331
Ortho-Clinical Diagnostics, Inc.
Immunology · 48d
Cleared Sep 12, 1997
MODIFICATION OF OPUS FERRITIN TEST SYSTEM
K973202
Behring Diagnostics, Inc.
Immunology · 66d
Cleared Jun 24, 1997
SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
K970612
Sealite Sciences, Inc.
Immunology · 126d
Cleared Dec 02, 1996
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K963170
Olympus America, Inc.
Immunology · 110d
Cleared Jul 05, 1995
UBI MAGIWEL FERRITIN QUANTITATIVE
K951993
United Biotech, Inc.
Immunology · 68d
Cleared Jun 20, 1995
AMERLITE FERRITIN II ASSAY
K952286
Johnson & Johnson Clinical Diagnostics, Inc.
Immunology · 35d
Cleared Mar 27, 1995
N LATEX FERRITIN
K950707
Behring Diagnostics, Inc.
Immunology · 40d
Cleared Jun 21, 1994
AXSYM FERRITIN
K935847
Abbott Laboratories
Immunology · 195d
Cleared Jan 28, 1994
DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
K935528
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 73d
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 Apr 05, 1991
SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
K911175
Serono-Baker Diagnostics, Inc.
Immunology · 18d
Cleared Mar 12, 1991
CIBA CORNING ACS FERRITIN IMMUNOASSAY
K905770
Ciba Corning Diagnostics Corp.
Immunology · 75d
Cleared Nov 29, 1990
ELEGANCE FERRITIN ELISA
K904822
Bioclone Australia Pty , Ltd.
Immunology · 36d
Cleared Apr 02, 1990
LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
K901075
London Diagnostics, Inc.
Immunology · 25d
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 Dec 27, 1988
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY
K884683
Serono-Baker Diagnostics, Inc.
Chemistry · 49d
Cleared Oct 27, 1988
MICROMEDIC FERRITIN IRMA KIT
K883746
Icn Micromedic Systems
Immunology · 56d