Atlas FDA

LDJ

150 FDA 510(k) clearances · Product code

81 daysmedian time to decision
210 days90th percentile
150clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Cannabinoids
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3870
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 (K232732)Co-Innovation Biotech Co., Ltd.2024-01-17
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) (K232604)Hangzhou Laihe Biotech Co., Ltd.2024-01-10
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT (K223162)Healgen Scientific,, LLC2023-03-17
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 (K192515)Shenzhen Bioeasy Biotechnology Co., Ltd.2019-10-11
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test (K153741)Hangzhou Clongene Biotech Co., Ltd.2016-03-18
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana (K152643)Nantong Egens Biotech Co., Ltd.2015-11-02
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set (K151203)Immunalysis Corporation2015-06-05
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls (K141320)Lin-Zhi International, Inc.2015-05-28
FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K142408)Polymed Therapeutics, Inc.2014-09-25
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST (K140546)Healgen Scientific,, LLC2014-06-06
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE (K130213)Lumiquick Diagnostics, Inc.2013-10-18
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR (K132096)Biophor Diagnostics, Inc.2013-10-18
TOXCUP DRUG SCREEN CUP (K122633)Branan Medical Corp.2013-02-07
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) (K122759)Omega Laboratories, Inc.2012-12-05
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST (K121557)Guangzhou Wondfo Biotech Co., Ltd.2012-07-25
PSYCHEMEDICS CANNABINOIDS EIA (K111929)Psychemedics Corp.2012-05-01
WUNDER TEST (K102428)Hien Helen Nguyen2012-04-18
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL (K110239)Lin-Zhi International, Inc.2011-06-23
CANNABINOIDS URINE TEST (K110182)Guangzhou Wondfo Biotech Co., Ltd.2011-05-20
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET (K092269)Randox Laboratories, Ltd.2011-04-08
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY (K101744)Microgenics Corp.2011-04-08
BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP (K082977)Mk Bio, Inc.2009-08-20
BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, (K080467)Applied Dna Technologies, Inc.2008-11-25
AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ (K080872)Amedica Biotech, Inc.2008-08-19
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K063164)Ortho-Clinical Diagnostics, Inc.2006-12-28
AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 (K061556)Amedica Biotech, Inc.2006-07-21
ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 (K053034)Acro Biotech, LLC2006-06-06
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE (K050936)ACON Laboratories, Inc.2005-06-24
ON CALL MULTI-DRUG HOME TEST CUP (K050878)ACON Laboratories, Inc.2005-06-08
NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE (K050594)Nano-Ditech Co.2005-05-15
ON CALL MULTI-DRUG HOME TEST (K050050)ACON Laboratories, Inc.2005-03-11
RANDOX CANNABINOIDS ASSSAY (K041142)Randox Laboratories, Ltd.2004-11-23
ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY (K041221)Accu-Stat Diagnostics, Inc.2004-07-13
QUEST DIAGNOSTICS HAIRCHECK-DT (THC) (K040257)Quest Diagnostics, Inc.2004-06-14
AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST (K040464)Amedica Biotech, Inc.2004-05-17
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE (K040629)Accu-Stat Diagnostics, Inc.2004-05-05
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI (K023648)Sun Biomedical Laboratories, Inc.2003-05-06
ONLINE DAT II CANNABINOIDS II (K030213)Roche Diagnostics Corp.2003-04-11
AMEDICA DRUG SCREEN THC TEST (K022955)Amedica Biotech, Inc.2002-11-06
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 (K021887)Lin-Zhi International, Inc.2002-08-15
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC (K014066)Princeton BioMeditech Corp.2002-06-10
LIFESIGN DOA 4 (THC/OPI/COC/MET) (K014193)Princeton BioMeditech Corp.2002-05-23
CANNABINOIDS (K013247)Abbott Laboratories2002-03-13
NO STEP ON SITE DEUG TEST CUP (K012390)Drug Free Enterprises2001-12-18
AMEDITECH IMMUTEST DRUG SCREEN THC (K011813)Ameditech, Inc.2001-10-22
MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET (K012541)Branan Medical Corp.2001-09-04
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST (K010921)Advantage Diagnostics Corp.2001-06-25
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 (K011300)Syva Co., Dade Behring, Inc.2001-05-17
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) (K003557)ACON Laboratories, Inc.2001-03-15
PROFILE II ER (K010138)Medtox Diagnostics, Inc.2001-02-14
LIVESURE THC SCREEN TEST (K010001)Pan Probe Biotech, Inc.2001-02-05
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I (K002375)OraSure Technologies, Inc.2001-01-26
BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST (K002263)Branan Medical Corp.2000-11-27
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST (K001126)Alatex Scientific, Inc.2000-08-07
FIRST CHECK HOME DRUG TEST PANEL 2 (K994139)Worldwide Medical Corp.2000-06-23
FIRST CHECK HOME DRUG TEST (THC) (K993663)Worldwide Medical Corp.2000-06-23
FIRST CHECK HOME DRUG TEST PANEL 3 (K994138)Worldwide Medical Corp.2000-06-23
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST (K994410)Alfa Scientific Designs, Inc.2000-06-21
ADVANTAGE THC TEST (K001567)Advantage Diagnostics Corp.2000-06-19
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 (K994164)Roche Diagnostics Corp.2000-04-13
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A (K000461)Dade Behring, Inc.2000-04-06
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 (K000131)Phamatech2000-02-04
RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) (K993961)American Bio Medica Corp.2000-01-24
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL (K993984)Syva Co.2000-01-18
AT HOME DRUG TEST, MODEL 9078 (K994220)Phamatech1999-12-30
SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST (K992949)Drug Detection Devices, Ltd.1999-12-27
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE (K993796)American Bio Medica Corp.1999-12-21
MICRO-STRIP FOR MARIJUANA METABOLITES (K991516)Microdiagnostics, Inc.1999-08-05
RAPIDONE - MARIJUANA TEST (K990818)American Bio Medica Corp.1999-07-07
REDI-TEST THC (K990870)Redwood Biotech, Inc.1999-04-27
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (K983701)Roche Diagnostic Systems, Inc.1998-12-11
DBEST TETRAHYDROCANNABINOL TEST KIT (K983188)Ameritek, Inc.1998-11-18
UBI MAGIWEL MARIJUANA METABOLITES (K973154)United Biotech, Inc.1998-07-22
GENIE CUP INTEGRATED SCREENING DEVICE (K980836)Applied Technology Ventures, LLC1998-06-29
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) (K981585)Roche Diagnostic Systems, Inc.1998-05-28
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) (K981584)Roche Diagnostic Systems, Inc.1998-05-28
STC CANNABINOIDS MICRO-PLATE EIA (K973750)OraSure Technologies, Inc.1998-02-13
QUICKSCREEN ONE STEP THC SCREENING TEST (K973122)Phamatech1997-09-25
ONE STEP MARIJUANA CARD TEST (K970548)Teco Diagnostics1997-07-03
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST (K971841)Bionike Laboratories, Inc.1997-06-25
IMMULITE CANNABINOIDS (K963916)Diagnostic Products Corp.1997-04-28
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST (K963654)Syntron Bioresearch, Inc.1997-02-28
QUICKPAC II ONE STEP MARIJUANA (THC) TEST (K963207)Drial Consultants, Inc.1997-02-20
VISUALINE COMBO V (COCAINE/THC) TEST (K963606)Sun Biomedical Laboratories, Inc.1996-10-30
VERDICT THC (K963516)Editek, Inc.1996-10-30
ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) (K951853)Tcpi, Inc.1996-08-20
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT (K955677)Beckman Instruments, Inc.1996-04-03
FRONTLINE CANNABIS (K954497)Boehringer Mannheim Corp.1996-03-06
VISUALINE II CANNABINOIDS (THC) (K950445)Sun Biomedical Laboratories, Inc.1995-05-02
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (K950181)E.I. Dupont DE Nemours & Co., Inc.1995-04-05
ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC (K945550)Princeton BioMeditech Corp.1995-02-22
EMIT IIC CANNABINOID ASSAY (K940158)Syva Co.1995-02-22
CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS (K944086)Beckman Instruments, Inc.1994-12-29
CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS (K944088)Beckman Instruments, Inc.1994-11-21
CANNABINOID EIA ASSAY (K943998)Diagnostic Reagents, Inc.1994-11-04
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION (K944562)Microgenics Corp.1994-11-02
CEDIA DAU MULTI-LEVEL THC ASSAY (K942337)Microgenics Corp.1994-08-01
USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 (K940912)U.S. Drug Testing, Inc.1994-06-02
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT (K940649)Microgenics Corp.1994-05-17
CEDIA DAU MULTI-LEVEL THC ASSAY (K935591)Microgenics Corp.1994-01-13
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