KXT · Class II · 21 CFR 862.3320

FDA Product Code KXT: Enzyme Immunoassay, Digoxin

Leading manufacturers include Syva Co., Microgenics Corp. and Abbott Laboratories.

85
Total
85
Cleared
86d
Avg days
1979
Since
85 devices
49–72 of 85
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 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 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
Cleared May 17, 1983
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
K831177
American Dade
Immunology · 36d
Cleared Nov 29, 1982
ENZYME-TEST DIGOXIN
K823199
Icl Scientific
Chemistry · 34d
Cleared Aug 12, 1981
ENDAB DIGOXIN KIT
K812054
Immunotech Corp.
Toxicology · 22d
Cleared Oct 10, 1980
OREIA-Q-DIG
K802358
Organon, Inc.
Toxicology · 14d
Cleared Jun 15, 1979
EMIT AUTO DIGOXIN ASSAY
K790937
Syva Co.
Toxicology · 28d
Cleared Apr 10, 1979
OREIA - DIGOXIN
K790521
Organon, Inc.
Toxicology · 25d
Cleared Mar 19, 1979
EMIT AUTO DIGOXIN ASSAY
K790303
Syva Co.
Toxicology · 34d