KXT · Class II · 21 CFR 862.3320

FDA Product Code KXT: Enzyme Immunoassay, Digoxin

Leading manufacturers include Syva Co., Microgenics Corp. and E.I. Dupont DE Nemours & Co., Inc..

85
Total
85
Cleared
86d
Avg days
1979
Since
85 devices
49–72 of 85
Cleared May 31, 1990
ENZYMUN TEST(R) DIGOXIN
K901216
Boehringer Mannheim Corp.
Toxicology · 78d
Cleared Sep 28, 1989
EZ-BEAD DIGOXIN EIA KIT
K893843
Immunotech Corp.
Toxicology · 126d
Cleared Aug 21, 1989
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910
Syva Co.
Toxicology · 83d
Cleared Mar 08, 1989
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528
Heraeus Kulzer, Inc.
Chemistry · 131d
Cleared Dec 02, 1988
MODIFICATION OF THE CEDIA DIGOXIN ASSAY
K884054
Microgenics Corp.
Chemistry · 67d
Cleared Jul 06, 1988
TDX (R) DIGOXIN NXT
K882233
Abbott Laboratories
Chemistry · 40d
Cleared May 31, 1988
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
K880823
Amersham Corp.
Toxicology · 91d
Cleared Aug 28, 1987
IQ DIGOXIN
K864223
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 304d
Cleared Aug 28, 1987
CEDIA DIGOXIN CR ASSAY
K872583
Microgenics Corp.
Chemistry · 59d
Cleared Apr 13, 1987
AFFINITY DIGOXIN IMMUNIT
K870552
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 62d
Cleared Apr 01, 1987
DIGOXIN FPIA REAGENT SET
K870951
Sigma Diagnostics, Inc.
Toxicology · 22d
Cleared Jan 05, 1987
DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
K864333
Windsor Laboratories, Inc.
Toxicology · 62d
Cleared Jul 11, 1986
DELFIA DIGOXIN
K861195
Lkb Instruments, Inc.
Toxicology · 102d
Cleared May 29, 1986
EMIT COLUMN DIGOXIN ASSAY
K861393
Syva Co.
Chemistry · 45d
Cleared May 29, 1986
EMIT DIGOXIN MOBILE PHASE SOLUTION
K861394
Syva Co.
Chemistry · 45d
Cleared Mar 25, 1986
CEDIA DIGOXIN ASSAY
K854638
Microgenics Corp.
Chemistry · 126d
Cleared Jan 22, 1986
V-TREND DIG ENZYME IMMUNOASSAY TEST KIT
K854972
V-Tech, Inc.
Chemistry · 42d
Cleared Apr 03, 1985
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
K851032
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 05, 1985
DUPONT DIGOXIN ASSAY REAGENTS
K850458
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 27d
Cleared Aug 16, 1984
EPSILON DIGOXIN TEST KIT
K842655
Beckman Instruments, Inc.
Toxicology · 37d
Cleared May 11, 1984
OPTIMATE DIGOXIN TEST
K841582
Miles Laboratories, Inc.
Toxicology · 24d
Cleared Apr 19, 1984
ACA DIGOXIN ANALYTICAL TEST PACK
K841107
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Mar 12, 1984
SENSIBEAD EIA DIGOXIN KIT
K840673
Terumo Medical Corp.
Chemistry · 26d
Cleared Jan 12, 1984
SYVA ADVANCE DIGOXIN ASSAY
K833791
Syva Co.
Toxicology · 73d