Product code KXT— Clinical Toxicology
CEDIA DIGOXIN PLUS ASSAY
- Classification name
- Enzyme Immunoassay, Digoxin
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Total cleared
- 85
- First cleared
- Most recent
Market context for product code KXT
FDA has cleared devices under product code KXT between 1979 and 2021, filed by 46 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2021
- 2016
- 2011
- 2010
- 2008
- 2006
- 2003
- 2002
- 2001
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
Top applicants under product code KXT
Recent clearances under product code KXT
- K193397 — ADVIA Centaur® Digoxin assay
- K153301 — Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
- K102346 — RANDOX DIGOXIN ASSAY
- K093441 — DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
- K082953 — ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
- K061249 — AXSYM DIGOXIN III
- K033007 — BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
- K023058 — QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
- K012301 — IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
- K011302 — RANDOX DIGOXIN
- K011920 — EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
- K983323 — DIGOXIN IMMUNOASSAY
- K983151 — IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
- K982935 — SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
- K980521 — DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
- K973112 — ELECSYS DIGOXIN
- K972794 — DIGOXIN DG-II FPIA REAGENT SET
- K970883 — CEDIA DIGOXIN II
- K970881 — CEDIA DIGOXIN
- K963062 — IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
- K963835 — DIGOXIN ENZYME IMMUNOASSAY
- K953718 — AXSYM DIGOXIN II
- K952079 — IMX DIGOXIN
- K951391 — IL TEST DIGOXIN, PN 181761-00
- K951441 — DUPONT ACA DIGOXIN (DGN A) METHOD
- K951755 — EMIT 2000 DIGOXIN ASSAY
- K943983 — IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS
- K946153 — DIGOXIN FLEX(TM) REAGENT CARTRIDGE
- K944506 — AXSYM DIGOXIN
- K943500 — EMIT 2000 DIGOXIN ASSAY
- K940569 — DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
- K941255 — CEDIA DIGOXIN PLUS ASSAY
- K940267 — ACE CLINICAL CHEMISTRY SYSTEM
- K934135 — EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
- K934168 — CEDIA DIGOXIN PLUS ASSAY
- K932732 — ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)
- K932250 — VIDAS DIGOXIN (DIG)
- K931123 — DIGOXIN TEST SYSTEM, KXT TX
- K931213 — ACS DIGOXIN IMMUNOASSAY
- K930162 — ACA DIGOXIN ANALYTICAL TEST PACK
- K924504 — FAST DIGOXIN TEST SYSTEM
- K925802 — ACCESS DIGOXIN ASSAY
- K924594 — DELFIA DIGOXIN KIT
- K923853 — CEDIA DIGOXIN PLUS ASSAY
- K920214 — CEDIA DIGOXIN ASSAY (MODIFICATION)
- K915602 — SRI DIGOXIN ENZYME IMMUNOASSAY
- K914151 — IL TEST(TM DIGOXIN
- K911941 — CEDIA(R) DIGOXIN R' ASSAY
- K910642 — CEDIA(R) DIGOXIN SC ASSAY
- K901547 — OPUS(TM) DIGOXIN TEST SYSTEM
- K901216 — ENZYMUN TEST(R) DIGOXIN
- K896863 — DIGOXIN-EIA-XT
- K893843 — EZ-BEAD DIGOXIN EIA KIT
- K894521 — FPR DIGOXIN KIT
- K893910 — EMIT CONVENIENCE PACK: DIGOXIN ASSAY
- K884528 — SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
- K884054 — MODIFICATION OF THE CEDIA DIGOXIN ASSAY
- K882233 — TDX (R) DIGOXIN NXT
- K880823 — AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
- K864223 — IQ DIGOXIN
- K872583 — CEDIA DIGOXIN CR ASSAY
- K870552 — AFFINITY DIGOXIN IMMUNIT
- K870951 — DIGOXIN FPIA REAGENT SET
- K864333 — DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
- K861195 — DELFIA DIGOXIN
- K861393 — EMIT COLUMN DIGOXIN ASSAY
- K861394 — EMIT DIGOXIN MOBILE PHASE SOLUTION
- K854638 — CEDIA DIGOXIN ASSAY
- K854972 — V-TREND DIG ENZYME IMMUNOASSAY TEST KIT
- K851032 — COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
- K850458 — DUPONT DIGOXIN ASSAY REAGENTS
- K842571 — IMMPULSE DIGOXIN ASSAY REAGENTS
- K842655 — EPSILON DIGOXIN TEST KIT
- K841582 — OPTIMATE DIGOXIN TEST
- K841107 — ACA DIGOXIN ANALYTICAL TEST PACK
- K840673 — SENSIBEAD EIA DIGOXIN KIT
- K833878 — VENTREZYME DIGOXIN IMMUNOASSAY DIGOX
- K833791 — SYVA ADVANCE DIGOXIN ASSAY
- K831177 — STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
- K823199 — ENZYME-TEST DIGOXIN
- K812054 — ENDAB DIGOXIN KIT
- K802358 — OREIA-Q-DIG
- K790937 — EMIT AUTO DIGOXIN ASSAY
- K790521 — OREIA - DIGOXIN
- K790303 — EMIT AUTO DIGOXIN ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.