Product code LDJ— Clinical Toxicology
CEDIA DAU MULTI-LEVEL THC ASSAY
- Classification name
- Enzyme Immunoassay, Cannabinoids
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Total cleared
- 150
- First cleared
- Most recent
Market context for product code LDJ
FDA has cleared devices under product code LDJ between 1981 and 2024, filed by 75 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- 2024
- 2023
- 2019
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2009
- 2008
- 2006
- 2005
- 2004
- 2003
Top applicants under product code LDJ
Recent clearances under product code LDJ
1–100 of 150- K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
- K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
- K223162 — Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
- K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
- K153741 — CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
- K152643 — EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
- K151203 — Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
- K141320 — LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
- K142408 — FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
- K140546 — HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
- K130213 — QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE
- K132096 — RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR
- K122633 — TOXCUP DRUG SCREEN CUP
- K122759 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)
- K121557 — WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
- K111929 — PSYCHEMEDICS CANNABINOIDS EIA
- K102428 — WUNDER TEST
- K110239 — LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
- K110182 — CANNABINOIDS URINE TEST
- K092269 — CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
- K101744 — THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
- K082977 — BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP
- K080467 — BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,
- K080872 — AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ
- K063164 — VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV
- K061556 — AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020
- K053034 — ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000
- K050936 — ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
- K050878 — ON CALL MULTI-DRUG HOME TEST CUP
- K050594 — NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE
- K050050 — ON CALL MULTI-DRUG HOME TEST
- K041142 — RANDOX CANNABINOIDS ASSSAY
- K041221 — ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY
- K040257 — QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
- K040464 — AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST
- K040629 — ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
- K023648 — VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
- K030213 — ONLINE DAT II CANNABINOIDS II
- K022955 — AMEDICA DRUG SCREEN THC TEST
- K021887 — CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
- K014066 — LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
- K014193 — LIFESIGN DOA 4 (THC/OPI/COC/MET)
- K013247 — CANNABINOIDS
- K012390 — NO STEP ON SITE DEUG TEST CUP
- K011813 — AMEDITECH IMMUTEST DRUG SCREEN THC
- K012541 — MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET
- K010921 — ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
- K011300 — EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
- K003557 — ACON THC ONE STEP MARIJUANA TEST STRIP(URINE); ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)
- K010138 — PROFILE II ER
- K010001 — LIVESURE THC SCREEN TEST
- K002375 — STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
- K002263 — BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST
- K001126 — PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
- K993663 — FIRST CHECK HOME DRUG TEST (THC)
- K994138 — FIRST CHECK HOME DRUG TEST PANEL 3
- K994139 — FIRST CHECK HOME DRUG TEST PANEL 2
- K994410 — INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
- K001567 — ADVANTAGE THC TEST
- K994164 — ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
- K000461 — URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
- K000131 — QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
- K993961 — RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)
- K993984 — SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
- K994220 — AT HOME DRUG TEST, MODEL 9078
- K992949 — SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST
- K993796 — RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE
- K991516 — MICRO-STRIP FOR MARIJUANA METABOLITES
- K990818 — RAPIDONE - MARIJUANA TEST
- K990870 — REDI-TEST THC
- K983701 — MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
- K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT
- K973154 — UBI MAGIWEL MARIJUANA METABOLITES
- K980836 — GENIE CUP INTEGRATED SCREENING DEVICE
- K981584 — ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
- K981585 — ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
- K973750 — STC CANNABINOIDS MICRO-PLATE EIA
- K973122 — QUICKSCREEN ONE STEP THC SCREENING TEST
- K970548 — ONE STEP MARIJUANA CARD TEST
- K971841 — BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
- K963916 — IMMULITE CANNABINOIDS
- K963654 — QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
- K963207 — QUICKPAC II ONE STEP MARIJUANA (THC) TEST
- K963516 — VERDICT THC
- K963606 — VISUALINE COMBO V (COCAINE/THC) TEST
- K951853 — ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
- K955677 — SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
- K954497 — FRONTLINE CANNABIS
- K950445 — VISUALINE II CANNABINOIDS (THC)
- K950181 — URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
- K940158 — EMIT IIC CANNABINOID ASSAY
- K945550 — ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC
- K944086 — CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS
- K944088 — CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS
- K943998 — CANNABINOID EIA ASSAY
- K944562 — MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
- K942337 — CEDIA DAU MULTI-LEVEL THC ASSAY
- K940912 — USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500
- K940649 — CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT
- K935591 — CEDIA DAU MULTI-LEVEL THC ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.