Enzyme Immunoassay, Cannabinoids
FDA product code LDJ · Class II (moderate risk) · 21 CFR 862.3870 · Clinical Toxicology
150510(k) clearances
1PMA approvals
15recalls
Manufacturers
- Syva Co. 17
- Roche Diagnostic Systems, Inc. 11
- Abbott Laboratories 8
- Microgenics Corp. 5
- Diagnostic Products Corp. 4
- ACON Laboratories, Inc. 4
- Amedica Biotech, Inc. 4
- Beckman Instruments, Inc. 3
- Princeton BioMeditech Corp. 3
- Sun Biomedical Laboratories, Inc. 3
- Lin-Zhi International, Inc. 3
- Phamatech 3
- Branan Medical Corp. 3
- American Bio Medica Corp. 3
- Worldwide Medical Corp. 3
- Microdiagnostics, Inc. 2
- V-Tech, Inc. 2
- Diagnostic Reagents, Inc. 2
- E.I. Dupont DE Nemours & Co., Inc. 2
- Keystone Diagnostics, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…LDJ · Traditional | Co-Innovation Biotech Co., Ltd. | 01/17/2024SE |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit…LDJ · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 01/10/2024SE |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTLDJ · Traditional | Healgen Scientific,, LLC | 03/17/2023SE |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 10/11/2019SE |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestLDJ · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 03/18/2016SE |
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…LDJ · Traditional | Nantong Egens Biotech Co., Ltd. | 11/02/2015SE |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…LDJ · Traditional | Immunalysis Corporation | 06/05/2015SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | Lin-Zhi International, Inc. | 05/28/2015SE |
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional | Polymed Therapeutics, Inc. | 09/25/2014SE |
| K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestLDJ · Traditional | Healgen Scientific,, LLC | 06/06/2014SE |
| K132096 | Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, CollectorLDJ · Traditional | Biophor Diagnostics, Inc. | 10/18/2013SE |
| K130213 | Quickprofile Single Drug of Abuse Device and Quick Profile Multi-Drugs of Abuse Screen…LDJ · Traditional | Lumiquick Diagnostics, Inc. | 10/18/2013SE |
| K122633 | Toxcup Drug Screen CupLDJ · Traditional | Branan Medical Corp. | 02/07/2013SE |
| K122759 | Omega Laboratories Hair Drug Screening Assay Cardoxy-Thc (Thca)LDJ · Traditional | Omega Laboratories, Inc. | 12/05/2012SE |
| K121557 | Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine TestLDJ · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 07/25/2012SE |
| K111929 | Psychemedics Cannabinoids EiaLDJ · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K102428 | Wunder TestLDJ · Traditional | Hien Helen Nguyen | 04/18/2012SE |
| K110239 | Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, ControlLDJ · Traditional | Lin-Zhi International, Inc. | 06/23/2011SE |
| K110182 | Cannabinoids Urine TestLDJ · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/20/2011SE |
| K101744 | Thermo Scientific Cedia Cannabinoids Oft AssayLDJ · Traditional | Microgenics Corp. | 04/08/2011SE |
| K092269 | Cannabinoid Assay and the Randox Cannabinoid Calibrator/ Control SetLDJ · Traditional | Randox Laboratories, Ltd. | 04/08/2011SE |
| K082977 | Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated CupLDJ · Special | Mk Bio, Inc. | 08/20/2009SE |
| K080467 | Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc…LDJ · Traditional | Applied Dna Technologies, Inc. | 11/25/2008SE |
| K080872 | Amedicheck Drug Screen THC, Coc, Opi, Amp, Met, PCP, Mdma,Bar, BZLDJ · Special | Amedica Biotech, Inc. | 08/19/2008SE |
| K063164 | Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat…LDJ · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/28/2006SE |
| K061556 | Amedica Drug Screen THC, Coc,Opi,Amp,Met,Pcp,Mdma,Bar,Bzo,; Model C1010,C1015,C1020LDJ · Special | Amedica Biotech, Inc. | 07/21/2006SE |
| K053034 | Acro Biotech LLC Rapid Tetrahydrocannabinol Urine Test; Catalog# OPI001000LDJ · Traditional | Acro Biotech, LLC | 06/06/2006SE |
| K050936 | On Call Home Drug Test for Marijuana and on Call Home Drug Test for Marijuana and CocaineLDJ · Traditional | ACON Laboratories, Inc. | 06/24/2005SE |
| K050878 | On Call Multi-Drug Home Test CupLDJ · Traditional | ACON Laboratories, Inc. | 06/08/2005SE |
| K050594 | Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine…LDJ · Traditional | Nano-Ditech Co. | 05/15/2005SE |
| K050050 | On Call Multi-Drug Home TestLDJ · Traditional | ACON Laboratories, Inc. | 03/11/2005SE |
| K041142 | Randox Cannabinoids AsssayLDJ · Traditional | Randox Laboratories, Ltd. | 11/23/2004SE |
| K041221 | Accu-Stat Home Drug Test Cup for Maijuanna (THC), Cocaine (Coc), Amphetamine (Amp)…LDJ · Traditional | Accu-Stat Diagnostics, Inc. | 07/13/2004SE |
| K040257 | Quest Diagnostics Haircheck-Dt (THC)LDJ · Traditional | Quest Diagnostics, Inc. | 06/14/2004SE |
| K040464 | Amedica Drug Screen Thc/Coc, OP1300, PPX, Oxy, Bar/Bzo TestLDJ · Traditional | Amedica Biotech, Inc. | 05/17/2004SE |
| K040629 | Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates…LDJ · Traditional | Accu-Stat Diagnostics, Inc. | 05/05/2004SE |
| K023648 | Visualine Cup IV for Drugs of Abuse Test for Qualitative Determination of Cocaine…LDJ · Traditional | Sun Biomedical Laboratories, Inc. | 05/06/2003SE |
| K030213 | Online Dat II Cannabinoids IILDJ · Abbreviated | Roche Diagnostics Corp. | 04/11/2003SE |
| K022955 | Amedica Drug Screen THC TestLDJ · Traditional | Amedica Biotech, Inc. | 11/06/2002SE |
| K021887 | Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071LDJ · Traditional | Lin-Zhi International, Inc. | 08/15/2002SE |
| K014066 | Lifesign THC, Status Stik THC, Accusign Stik THC, Lifesign Marijuana, Accustik THCLDJ · Traditional | Princeton BioMeditech Corp. | 06/10/2002SE |
| K014193 | Lifesign Doa 4 (Thc/Opi/Coc/Met)LDJ · Traditional | Princeton BioMeditech Corp. | 05/23/2002SE |
| K013247 | CannabinoidsLDJ · Traditional | Abbott Laboratories | 03/13/2002SE |
| K012390 | No Step on Site Deug Test CupLDJ · Traditional | Drug Free Enterprises | 12/18/2001SE |
| K011813 | Ameditech Immutest Drug Screen THCLDJ · Traditional | Ameditech, Inc. | 10/22/2001SE |
| K012541 | Modification To:Fastix Thc/Coc Drug Screen Dipstick Test, Fastix Thc/Coc/Met Drug Screen…LDJ · Special | Branan Medical Corp. | 09/04/2001SE |
| K010921 | Advantage Marijuana (THC) Home Drug TestLDJ · Traditional | Advantage Diagnostics Corp. | 06/25/2001SE |
| K011300 | Emit II Plus Cannabinoid Assay, Model OSR9N229LDJ · Special | Syva Co., Dade Behring, Inc. | 05/17/2001SE |
| K003557 | Acon THC One Step Marijuana Test Strip(Urine);Acon THC One Step Marijuana Test Device…LDJ · Traditional | ACON Laboratories, Inc. | 03/15/2001SE |
| K010138 | Profile II ErLDJ · Special | Medtox Diagnostics, Inc. | 02/14/2001SE |
| K010001 | Livesure THC Screen TestLDJ · Traditional | Pan Probe Biotech, Inc. | 02/05/2001SE |
| K002375 | STC Cannabinoids Intercept Micro-Plate Eia, Model 1118ILDJ · Traditional | OraSure Technologies, Inc. | 01/26/2001SE |
| K002263 | Branan Medical Corporartion Monitect THC Drug Screen TestLDJ · Traditional | Branan Medical Corp. | 11/27/2000SE |
| K001126 | Peace of Mind Multiple Drugs of Abuse TestLDJ · Traditional | Alatex Scientific, Inc. | 08/07/2000SE |
| K994139 | First Check Home Drug Test Panel 2LDJ · Traditional | Worldwide Medical Corp. | 06/23/2000SE |
| K994138 | First Check Home Drug Test Panel 3LDJ · Traditional | Worldwide Medical Corp. | 06/23/2000SE |
| K993663 | First Check Home Drug Test (THC)LDJ · Traditional | Worldwide Medical Corp. | 06/23/2000SE |
| K994410 | Instant-View Marijuana (THC) Urine Dip Strip TestLDJ · Traditional | Alfa Scientific Designs, Inc. | 06/21/2000SE |
| K001567 | Advantage THC TestLDJ · Traditional | Advantage Diagnostics Corp. | 06/19/2000SE |
| K994164 | Ontrak Teststik 2 for Cocaine/Thc, Cat. 1118579LDJ · Traditional | Roche Diagnostics Corp. | 04/13/2000SE |
| K000461 | Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog No. DF 95ALDJ · Traditional | Dade Behring, Inc. | 04/06/2000SE |
| K000131 | Quickscreen Pro Multi Drug Screening Test, Model 9153 PAT04LDJ · Special | Phamatech | 02/04/2000SE |
| K993961 | Rapid Drug Screen 3-PANEL Test for Cocaine, Marijuana (THC) (Cannabinoids) and Opiates…LDJ · Traditional | American Bio Medica Corp. | 01/24/2000SE |
| K993984 | Syva Emit II Plus Cannabinoid Assay, Models 9N029UL/9N129ULLDJ · Traditional | Syva Co. | 01/18/2000SE |
| K994220 | At Home Drug Test, Model 9078LDJ · Special | Phamatech | 12/30/1999SE |
| K992949 | Screeners Marijuana Test, Drugscreen Dip Marijuana TestLDJ · Traditional | Drug Detection Devices, Ltd. | 12/27/1999SE |
| K993796 | Rapid Drug Screen 5-PANEL Drug Screening Test for Cocaine, Marijuana, Opiates…LDJ · Traditional | American Bio Medica Corp. | 12/21/1999SE |
| K991516 | Micro-Strip for Marijuana MetabolitesLDJ · Traditional | Microdiagnostics, Inc. | 08/05/1999SE |
| K990818 | Rapidone - Marijuana TestLDJ · Traditional | American Bio Medica Corp. | 07/07/1999SE |
| K990870 | Redi-Test THCLDJ · Traditional | Redwood Biotech, Inc. | 04/27/1999SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | Roche Diagnostic Systems, Inc. | 12/11/1998SE |
| K983188 | Dbest Tetrahydrocannabinol Test KitLDJ · Traditional | Ameritek, Inc. | 11/18/1998SE |
| K973154 | Ubi Magiwel Marijuana MetabolitesLDJ · Traditional | United Biotech, Inc. | 07/22/1998SE |
| K980836 | Genie Cup Integrated Screening DeviceLDJ · Traditional | Applied Technology Ventures, LLC | 06/29/1998SE |
| K981585 | Abuscreen Online for Cannabinoids (1000 Test Kit)LDJ · Traditional | Roche Diagnostic Systems, Inc. | 05/28/1998SE |
| K981584 | Abuscreen Online for Cannabinoids (100 Test Kit)LDJ · Traditional | Roche Diagnostic Systems, Inc. | 05/28/1998SE |
| K973750 | STC Cannabinoids Micro-Plate EiaLDJ · Traditional | OraSure Technologies, Inc. | 02/13/1998SE |
| K973122 | Quickscreen One Step THC Screening TestLDJ · Traditional | Phamatech | 09/25/1997SE |
| K970548 | One Step Marijuana Card TestLDJ · Traditional | Teco Diagnostics | 07/03/1997SE |
| K971841 | Bionike Aq One Step Cannabinoids (THC) TestLDJ · Traditional | Bionike Laboratories, Inc. | 06/25/1997SE |
| K963916 | Immulite CannabinoidsLDJ · Traditional | Diagnostic Products Corp. | 04/28/1997SE |
| K963654 | Quikstrip Onestep Marijuana (THC) TestLDJ · Traditional | Syntron Bioresearch, Inc. | 02/28/1997SE |
| K963207 | Quickpac II One Step Marijuana (THC) TestLDJ · Traditional | Drial Consultants, Inc. | 02/20/1997SE |
| K963606 | Visualine Combo V (Cocaine/Thc) TestLDJ · Traditional | Sun Biomedical Laboratories, Inc. | 10/30/1996SE |
| K963516 | Verdict THCLDJ · Traditional | Editek, Inc. | 10/30/1996SE |
| K951853 | One Step Urine Drug of Abuse Cannabinoid Test (THC)LDJ · Traditional | Tcpi, Inc. | 08/20/1996SE |
| K955677 | Synchron Systems Cannabinoid 20 NG ReagentLDJ · Traditional | Beckman Instruments, Inc. | 04/03/1996SE |
| K954497 | Frontline CannabisLDJ · Traditional | Boehringer Mannheim Corp. | 03/06/1996SE |
| K950445 | Visualine II Cannabinoids (THC)LDJ · Traditional | Sun Biomedical Laboratories, Inc. | 05/02/1995SE |
| K950181 | Urine Cannabinoids Screen Flex(Tm) Reagent CartridgeLDJ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/05/1995SE |
| K945550 | Abusign(Tm) THC, Doa-Thc, Accusign(Tm) THC, Doa-Thc, Diosign(Tm) THC, Doa-ThcLDJ · Traditional | Princeton BioMeditech Corp. | 02/22/1995SE |
| K940158 | Emit Iic Cannabinoid AssayLDJ · Traditional | Syva Co. | 02/22/1995SE |
| K944086 | Cx(Tm) Cannabinoid 50NG(THC5) Reagent/Synchron CX SysLDJ · Traditional | Beckman Instruments, Inc. | 12/29/1994SE |
| K944088 | Cx(Tm) Cannabinoid 100 Ng(Thc) Reagent/Synchron CX SysLDJ · Traditional | Beckman Instruments, Inc. | 11/21/1994SE |
| K943998 | Cannabinoid Eia AssayLDJ · Traditional | Diagnostic Reagents, Inc. | 11/04/1994SE |
| K944562 | Multi Level THC Assay, Synchron CX Reagent ApplicationLDJ · Traditional | Microgenics Corp. | 11/02/1994SE |
| K942337 | Cedia Dau Multi-Level THC AssayLDJ · Traditional | Microgenics Corp. | 08/01/1994SE |
| K940912 | Usdt Cannabinoid (THC) Assay Column Catalog No. 9000-500LDJ · Traditional | U.S. Drug Testing, Inc. | 06/02/1994SE |
| K940649 | Cedia Dau Multi-Level THC Assay, Hitachi 911 Reagent/ and the Hitachi 747 ReagentLDJ · Traditional | Microgenics Corp. | 05/17/1994SE |
| K935591 | Cedia Dau Multi-Level THC AssayLDJ · Traditional | Microgenics Corp. | 01/13/1994SE |
| K932716 | Emit(R) THC 50/100 NG AssayLDJ · Traditional | Syva Co. | 10/01/1993SE |
| K931598 | Biosite Triage Panel for Drugs of ABUSE(50NG/ML)LDJ · Traditional | Biosite Incorporated | 05/12/1993SE |
| K930654 | STC Diagnostics Auto-Lyte Cannabinoids EiaLDJ · Traditional | Solarcare Technologies Corp,Inc. | 05/06/1993SE |
| K924815 | Microplate Cannabinoids AssayLDJ · Traditional | Solarcare Technologies Corp,Inc. | 01/26/1993SE |
| K920418 | Il Test Cannabinoid, 35282LDJ · Traditional | Instrumentation Laboratory CO | 02/27/1992SE |
| K920311 | Cannabinoid Eia TestLDJ · Traditional | Diagnostic Reagents, Inc. | 02/27/1992SE |
| K914915 | Microline Screen for CannabinoidLDJ · Traditional | Drug Screening Systems, Inc. | 01/22/1992SE |
| K914490 | Micro Eia for Marijuana MetabolitesLDJ · Traditional | Microdiagnostics, Inc. | 11/29/1991SE |
| K912757 | Abuscreen Radioimmunoassay for CannabiniodsLDJ · Traditional | Roche Diagnostic Systems, Inc. | 07/26/1991SE |
| K910592 | Abuscreen FP for Cannabinoids (15-50)LDJ · Traditional | Roche Diagnostic Systems, Inc. | 06/21/1991SE |
| K910893 | Target(Tm) Cannabinoids-R TestLDJ · Traditional | V-Tech, Inc. | 04/03/1991SE |
| K910892 | Target(Tm) Cannabinoids-V TestLDJ · Traditional | V-Tech, Inc. | 04/03/1991SE |
| K910589 | Abuscreen FP for Cannabinoids (50-100)LDJ · Traditional | Roche Diagnostic Systems, Inc. | 04/03/1991SE |
| K904571 | Emit(R) II Cannabinoid 50 NG AssayLDJ · Traditional | Syva Co. | 12/26/1990SE |
| K904570 | Emit(R) II Cannabinoid 20 NG AssayLDJ · Traditional | Syva Co. | 12/26/1990SE |
| K904568 | Emit(R) II Cannabinoid 100 NG AssayLDJ · Traditional | Syva Co. | 12/26/1990SE |
| K904856 | Abuscreen Ontrak for THCLDJ · Traditional | Roche Diagnostic Systems, Inc. | 12/13/1990SE |
| K904541 | Labeling Submittal, Adx TM Cannabinoids-GsLDJ · Traditional | Abbott Laboratories | 11/20/1990SE |
| K904635 | Microzyme THC Enzyme Immunoassay Test KitLDJ · Traditional | Immunotech Corp. | 11/01/1990SE |
| K901568 | Milenia(Tm) CannabinoidsLDJ · Traditional | Diagnostic Products Corp. | 05/17/1990SE |
| K901334 | Hycor Accupinch THC TestLDJ · Traditional | Hycor Biomedical, Inc. | 05/14/1990SE |
| K890693 | Adx CannabinoidsLDJ · Traditional | Abbott Laboratories | 08/25/1989SE |
| K874390 | Crack-It Cannabinoid ScreenLDJ · Traditional | Sakers, Inc. | 04/10/1989SE |
| K890887 | Abuscreen FP for CannabinoidsLDJ · Traditional | Roche Diagnostic Systems, Inc. | 03/16/1989SE |
| K883731 | TDX Cannabinoids-GsLDJ · Traditional | Abbott Laboratories | 10/11/1988SE |
| K882313 | Emit D.A.U. Cannabinoid 50 NG Assay & CalibratorsLDJ · Traditional | Syva Co. | 08/29/1988SE |
| K882819 | Emit Hva Cannabinoid 100 NG AssayLDJ · Traditional | Syva Co. | 08/08/1988SE |
| K881814 | Abuscreen(R) Ontrak(Tm) for THCLDJ · Traditional | Roche Diagnostic Systems, Inc. | 07/29/1988SE |
| K875219 | Modification to Kdi Quik Test Marijuana ScreenLDJ · Traditional | Keystone Diagnostics, Inc. | 06/24/1988SE |
| K882362 | Stat Fix Microwave Irradiation MediumLDJ · Traditional | Stat Path | 06/22/1988SE |
| K880015 | Revised Labeling for Adx CannabinoidsLDJ · Traditional | Abbott Laboratories | 03/01/1988SE |
| K875252 | Aca du Pont Urine Cannabinoids (U THC) Screen MethLDJ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 02/03/1988SE |
| K874646 | TDXR DELTA-9-CANNABINOIDSLDJ · Traditional | Abbott Laboratories | 12/18/1987SE |
| K874488 | Revised Labeling for TDX CannabinoidsLDJ · Traditional | Abbott Laboratories | 11/23/1987SE |
| K874269 | Revised Labeling for Cannabinoids Test KitLDJ · Traditional | Roche Diagnostic Systems, Inc. | 11/20/1987SE |
| K872882 | Cannabinoid Enzyme Immunoassay KitLDJ · Traditional | General Diagnostics | 11/03/1987SE |
| K874156 | Sticker Label for Drugs of Abuse AssaysLDJ · Traditional | Syva Co. | 10/28/1987SE |
| K874079 | Revised Labeling for Syva Cannabinoid AssaysLDJ · Traditional | Syva Co. | 10/28/1987SE |
| K873753 | Labeling Change Cannabinoids Double Anti. in UrineLDJ · Traditional | Diagnostic Products Corp. | 10/15/1987SE |
| K871695 | Double Antibody Cannabinoids KTHD1 and KTHD5LDJ · Traditional | Diagnostic Products Corp. | 06/05/1987SE |
| K870197 | Kdi Quik Test(Tm) Marijuana ScreenLDJ · Traditional | Keystone Diagnostics, Inc. | 06/01/1987SE |
| K870377 | Abuscreen (R) Eia CannabinoidsLDJ · Traditional | Roche Diagnostic Systems, Inc. | 03/16/1987SE |
| K864751 | TDXR CannabinoidsLDJ · Traditional | Abbott Laboratories | 03/13/1987SE |
| K860500 | Emit D.A.U. Cannabinoid 20NG AssayLDJ · Traditional | Syva Co. | 04/11/1986SE |
| K851373 | Emit 700 Cannabinoid 20 AssayLDJ · Traditional | Syva Co. | 05/01/1985SE |
| K843421 | Emit 700 Cannabinoid AssayLDJ · Traditional | Syva Co. | 09/25/1984SE |
| K841238 | Emit ST Urine Cannabinoid AssayLDJ · Traditional | Syva Co. | 06/21/1984SE |
| K834458 | Emit D.A.U. Urine Cannabinoid AssayLDJ · Traditional | Syva Co. | 06/21/1984SE |
| K833580 | Modif. of Emit Urine CannabinoidLDJ · Traditional | Syva Co. | 01/26/1984SE |
| K812195 | Emit-St Cannabinoid AssayLDJ · Traditional | Syva Co. | 08/20/1981SE |
PMA approvals
- P950040 Dr. Brown's Home Drug Testing Kit · Personal Health & Hygiene, Inc. · 01/21/1997
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0262-2024 Class II | AT HOME MARIJUANA TEST STRIP, SKU 900752Products were stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. | 10/04/2023Open, Classified |
| Z-1542-2022 Class II | AT HOME MARIJUANA TEST STRIP, SKU 900752Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… | Family Dollar Stores, Llc. | 06/23/2022Open, Classified |
| Z-3047-2020 Class II | First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700BVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3041-2020 Class II | Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE…XXX | Ameditech Inc | 08/18/2020Terminated |
| Z-3040-2020 Class II | iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup"…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3039-2020 Class II | Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup"…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3035-2020 Class II | Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3033-2020 Class II | Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3032-2020 Class II | CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-1701-2020 Class II | SPICE (JWH-018) CC443Corrections are being made to the device labeling regarding its intended use, to include a statement… | Carolina Liquid Chemistries Corp | 02/10/2020Terminated |
| Z-2050-2013 Class II | SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY…These products are being recalled because they were distributed without adequate labeling and instructions… | Sarken, Inc. | 07/29/2013Terminated |
| Z-0481-2009 | Cannabinoids Intercept Micro Plate EIA 100 plate kitReadings, high: intermittent high absorbance readings. For further information, please contact the firm at… | OraSure Technologies, Inc. | 09/08/2008Terminated |
| Z-0479-2009 | Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro…Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information… | OraSure Technologies, Inc. | 09/08/2008Terminated |
| Z-0478-2009 | Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro…Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information… | OraSure Technologies, Inc. | 09/08/2008Terminated |
| Z-0477-2009 | Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro…Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information… | OraSure Technologies, Inc. | 09/08/2008Terminated |