Enzyme Immunoassay, Opiates
FDA product code DJG · Class II (moderate risk) · 21 CFR 862.3650 · Clinical Toxicology
215510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Lin-Zhi International, Inc. 16
- Microgenics Corp. 13
- Immunalysis Corporation 11
- Syva Co. 8
- Guangzhou Wondfo Biotech Co., Ltd. 8
- Medtox Diagnostics, Inc. 7
- Diagnostic Products Corp. 6
- Phamatech 6
- ACON Laboratories, Inc. 6
- Abbott Laboratories 5
- Roche Diagnostic Systems, Inc. 5
- Psychemedics Corp. 5
- Tianjin New Bay Bioresearch Co., Ltd. 5
- Randox Laboratories, Ltd. 5
- Princeton BioMeditech Corp. 4
- Chemtron Biotech, Inc. 4
- Siemens Healthcare Diagnostics, Inc. 4
- American Bio Medica Corp. 4
- Ark Diagnostics, Inc. 4
- Solarcare Technologies Corp,Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | Medtox Diagnostics, Inc. | 01/29/2026SE |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 01/23/2026SE |
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | Immunalysis Corporation | 09/11/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | Healgen Scientific,, LLC | 08/15/2025SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette)…DJG · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 01/09/2024SE |
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…DJG · Traditional | Chemtron Biotech, Inc. | 12/20/2023SE |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 12/13/2023SE |
| K231752 | ARK Hydrocodone AssayDJG · Traditional | Ark Diagnostics, Inc. | 11/09/2023SE |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 10/05/2023SE |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATDJG · Traditional | Randox Laboratories Limited | 10/05/2023SE |
| K231007 | CEDIA Heroin Metabolite (6-AM) AssayDJG · Traditional | Microgenics Corporation | 09/27/2023SE |
| K231698 | AllTest Fentanyl Rapid Test (Urine)DJG · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 07/31/2023SE |
| K221605 | Emit® II Plus Buprenorphine AssayDJG · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2023SE |
| K230238 | BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup RxDJG · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 03/31/2023SE |
| K222955 | Xenta Drug Screen Cup, Xenta Drug Screen DipcardDJG · Traditional | Xenta Biomedical Science Co., Ltd. | 02/06/2023SE |
| K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11DJG · Traditional | Shenzhen Superbio Technology Co., Ltd. | 12/13/2022SE |
| K203527 | Immunalysis Tapentadol Urine HEIADJG · Traditional | Lmmunalysis Corporation | 05/09/2022SE |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayDJG · Traditional | Immunalysis Corporation | 12/22/2021SE |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsDJG · Traditional | Assure Tech. (Hangzhou) Co, Ltd. | 08/12/2021SE |
| K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics…DJG · Traditional | Psychemedics Corporation | 07/27/2021SE |
| K202007 | LZI Oxycodone III Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 09/17/2020SE |
| K201494 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardDJG · Traditional | Advin Biotech, Inc. | 09/17/2020SE |
| K201938 | LZI Fentanyl II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 08/07/2020SE |
| K201223 | LZI Tramadol Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 06/04/2020SE |
| K200197 | ARK Fentanyl II AssayDJG · Traditional | Ark Diagnostics, Inc. | 02/26/2020SE |
| K192943 | CEDIA Heroin Metabolite (6-AM) assayDJG · Traditional | Microgenics Corporation | 12/16/2019SE |
| K182103 | Psychemedics Microplate EIA for Fentanyl in HairDJG · Traditional | Psychemedics Corporation | 04/18/2019SE |
| K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardDJG · Traditional | Advin Biotech, Inc. | 03/29/2019SE |
| K182280 | ARK Tramadol AssayDJG · Traditional | Ark Diagnostics, Inc. | 12/10/2018SE |
| K181159 | LZI Fentanyl Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 12/03/2018SE |
| K180427 | ARK Fentanyl AssayDJG · Traditional | Ark Diagnostics, Inc. | 06/06/2018SE |
| K172416 | Synermed Opiate Enzyme ImmunoassayDJG · Traditional | Infrared Laboratory Systems, LLC (Dba Synermed) | 04/19/2018SE |
| K173195 | DRI Hydrocodone AssayDJG · Traditional | Microgenics Corporation | 02/13/2018SE |
| K173183 | CEDIA Heroin Metabolite (6-AM) AssayDJG · Traditional | Microgenics Corporation | 11/22/2017SE |
| K172910 | Emit II Plus Oxycodone AssayDJG · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/18/2017SE |
| K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine…DJG · Traditional | Immunalysis Corporation | 06/14/2017SE |
| K163101 | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative…DJG · Traditional | Microgenics Corporation | 04/06/2017SE |
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardDJG · Special | Co-Innovation Biotech Co., Ltd. | 04/26/2016SE |
| K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…DJG · Traditional | Chemtron Biotech, Inc. | 04/18/2016SE |
| K152551 | First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse…DJG · Traditional | W.H.P.M., Inc. | 11/09/2015SE |
| K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level…DJG · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/23/2015SE |
| K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsDJG · Traditional | Microgenics Corporation | 10/09/2015SE |
| K151478 | Wondfo CR3 Keyless Split Sample CupDJG · Special | Guangzhou Wondfo Biotech Co., Ltd. | 07/01/2015SE |
| K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300…DJG · Traditional | Immunalysis Corporation | 05/20/2015SE |
| K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000DJG · Traditional | Chemtron Biotech, Inc. | 04/17/2015SE |
| K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine…DJG · Traditional | Immunalysis Corporation | 03/09/2015SE |
| K150179 | CR3 Keyless Split Sample Cup Oxycodone - CannabinoidsDJG · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 02/25/2015SE |
| K141205 | Lzi Oral Fluid 6-ACETYLMORPHINE Enzyme Immunoassay, Lzi Oral Fluid 6-ACETYLMORPHINE…DJG · Traditional | Lin-Zhi International, Inc. | 02/13/2015SE |
| K141803 | Immunalysis Tramadol Urine Enzyme ImmunoassayDJG · Traditional | Immunalysis Corporation | 02/12/2015SE |
| K143187 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test…DJG · Traditional | Healgen Scientific,, LLC | 01/27/2015SE |
| K140671 | Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and HydrocodoneDJG · Traditional | Omega Laboratories, Inc. | 01/08/2015SE |
| K142280 | Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip…DJG · Traditional | Healgen Scientific,, LLC | 10/16/2014SE |
| K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsDJG · Traditional | Chemtron Biotech, Inc. | 10/09/2014SE |
| K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 08/20/2014SE |
| K141406 | Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine…DJG · Traditional | Immunalysis Corporation | 07/01/2014SE |
| K141055 | Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML)DJG · Traditional | Lin-Zhi International, Inc. | 06/13/2014SE |
| K140089 | CR3 Keyless Split Sample Cup(Opi-Bzo)DJG · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 04/08/2014SE |
| K130650 | Status DS OxyDJG · Traditional | Princeton BioMeditech Corp. | 02/26/2014SE |
| K133642 | Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid Calibrators, Controls…DJG · Traditional | Biophor Diagnostics, Inc. | 01/24/2014SE |
| K131168 | Immunalysis Oxycodone Enzyme ImmunoassayDJG · Traditional | Immunalysis Corporation | 01/17/2014SE |
| K130275 | Quikscreen Multi (Mdma and Opi) OTC Drug Cup TestDJG · Traditional | Tianjin New Bay Bioresearch Co., Ltd. | 09/26/2013SE |
| K122064 | Forsure One Step Buprenorphine Cup Test DeviceDJG · Traditional | Tianjin New Bay Bioresearch Co., Ltd. | 05/07/2013SE |
| K130665 | Wondofo Multi-Drug Urine Test Cup / PanelDJG · Special | Guangzhou Wondfo Biotech Co., Ltd. | 04/09/2013SE |
| K130055 | Acon Bup One Step Buprenorphine Test StripDJG · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 02/14/2013SE |
| K123799 | Psychemedics Microplate Eia for Oxycodone in HairDJG · Traditional | Psychemedics Corp. | 02/08/2013SE |
| K113747 | Randox Opiates AssayDJG · Traditional | Randox Laboratories Limited | 08/24/2012SE |
| K120763 | Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone…DJG · Traditional | Lin-Zhi International, Inc. | 06/01/2012SE |
| K120761 | Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate…DJG · Traditional | Lin-Zhi International, Inc. | 05/08/2012SE |
| K111926 | Psychemedics Opiates EiaDJG · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K113624 | Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine TestDJG · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 03/12/2012SE |
| K103161 | Omega Laboratories Hair Drug Screening Assay for OpiatesDJG · Traditional | Omega Laboratories, Inc. | 12/13/2011SE |
| K112310 | Wondfo Methadone Urine Test,Opiate TestDJG · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 09/08/2011SE |
| K110298 | Opiate Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 07/15/2011SE |
| K101754 | Thermo Scientific Cedia Opiate Oft AssayDJG · Traditional | Microgenics Corp. | 04/08/2011SE |
| K102779 | Emit II PLUS6-ACETYLMORPHINE Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level…DJG · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/18/2011SE |
| K093867 | Roche Oral Fluid Opiates, Dat Qual Cal a, Dat Control Set a and Dat SQ Cal aDJG · Traditional | Roche Diagnostics | 02/11/2011SE |
| K100951 | Medtox Buprenorphine TestDJG · Traditional | Medtox Diagnostics, Inc. | 10/18/2010SE |
| K093175 | Wondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test, Propoxphene Urine Test…DJG · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 08/25/2010SE |
| K101195 | 6-ACETYLMORPHINE Enzyme Immunoassay with 6-ACETYLMORPHINE Calibrators and ControlsDJG · Traditional | Lin-Zhi International, Inc. | 07/06/2010SE |
| K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…DJG · Abbreviated | Alfa Scientific Designs, Inc. | 07/06/2010SE |
| K100023 | Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemDJG · Traditional | Medtox Diagnostics, Inc. | 04/05/2010SE |
| K091612 | Ucp Rapid Drug Screening Buprenorphine, Amp 300, Mamp 500, Coc 150 Test;DJG · Traditional | Ucp Biosciences, Inc. | 02/24/2010SE |
| K090844 | Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and ControlsDJG · Traditional | Lin-Zhi International, Inc. | 07/30/2009SE |
| K091454 | Profile-V Medtoxscan Drugs of Abuse Test SystemDJG · Traditional | Medtox Diagnostics, Inc. | 07/24/2009SE |
| K081008 | Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron…DJG · Traditional | Lin-Zhi International, Inc. | 12/22/2008SE |
| K082508 | Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen DipcardDJG · Traditional | Branan Medical Corporation | 11/21/2008SE |
| K063699 | Imdx SystemsDJG · Traditional | Novx Systems, Inc. | 06/01/2007SE |
| K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test(Cassette…DJG · Abbreviated | Alfa Scientific Designs, Inc. | 05/07/2007SE |
| K063015 | Ameditech Immutest Multi-Drug Screen BUP/PPX/COC150DJG · Traditional | Ameditech, Inc. | 12/20/2006SE |
| K062460 | Vitros Chemistry Products Op Reagent, Calibrator Kit 26 and Dat Performance Verifiers I…DJG · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/15/2006SE |
| K060760 | Rapidone-Buprenorphine TestDJG · Traditional | American Bio Medica Corp. | 08/07/2006SE |
| K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…DJG · Abbreviated | Alfa Scientific Designs, Inc. | 07/25/2006SE |
| K051958 | MP Rapidoxy Test Strip, Model 07RD-7073DJG · Traditional | Mp Biomedicals, LLC | 07/21/2006SE |
| K053037 | Acro Biotech LLC Rapid Opiates Urine Test; Catalog# OPI00100DJG · Traditional | Acro Biotech, LLC | 06/15/2006SE |
| K060351 | Medtox OxycodoneDJG · Traditional | Medtox Diagnostics, Inc. | 05/12/2006SE |
| K052520 | Rapid Forsure One Step Multiple Drug (Up to 6) Screen Test Device for Amphetamine…DJG · Traditional | Tianjin New Bay Bioresearch Co., Ltd. | 04/24/2006SE |
| K060466 | Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test…DJG · Traditional | ACON Laboratories, Inc. | 04/21/2006SE |
| K051626 | Immunalysis Opiates Elisa for Oral FluidsDJG · Traditional | Immunalysis Corporation | 10/13/2005SE |
| K042725 | Quest Diagnostics Haircheck-Dt (Opiates)DJG · Traditional | Quest Diagnostics, Inc. | 07/06/2005SE |
| K050733 | Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsDJG · Traditional | Lin-Zhi International, Inc. | 06/13/2005SE |
| K042988 | Rapid One Step Buprenorphine Test CardDJG · Traditional | Tianjin New Bay Bioresearch Co., Ltd. | 05/12/2005SE |
| K042990 | For Sure One Step Buprenorphine Test StripDJG · Traditional | Tianjin New Bay Bioresearch Co., Ltd. | 05/10/2005SE |
| K043507 | Acon Oxy II One Step Oxycodone Test Strip; Test DeviceDJG · Traditional | ACON Laboratories, Inc. | 02/25/2005SE |
| K043051 | Quickscreen Oxycodone Test, Models 9120, 9120T, 9120X and 9121DJG · Traditional | Phamatech, Inc. | 02/07/2005SE |
| K041747 | Impact Test System Saliva Test Module-Opiate (Workplace)DJG · Traditional | Lifepoint,Inc | 11/24/2004SE |
| K041746 | Impact Test System; Saliva Test Module-Opiate (Prescription Use)DJG · Traditional | Lifepoint,Inc | 11/23/2004SE |
| K041144 | Randox Opiates AssayDJG · Traditional | Randox Laboratories, Ltd. | 11/03/2004SE |
| K040316 | Cedia Buprenorphine AssayDJG · Traditional | Microgenics Corp. | 06/23/2004SE |
| K040274 | Acon Opi One Step Opiate Test Strip and Acon Opi One Step Opiate Test DeviceDJG · Traditional | ACON Laboratories, Inc. | 05/03/2004SE |
| K033047 | Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test DeviceDJG · Traditional | ACON Laboratories, Inc. | 02/17/2004SE |
| K031032 | Verdict II, Profile IIDJG · Special | Medtox Diagnostics, Inc. | 07/14/2003SE |
| K030113 | Monitect Oxycodone Drug Screen Cassette Test, Model MC 23, Fastect Oxycodone Drug Screen…DJG · Traditional | Branan Medical Corp. | 07/02/2003SE |
| K031002 | Synchron Systems Opiate ReagentDJG · Special | Beckman Coulter, Inc. | 04/29/2003SE |
| K023047 | Amedica Drug Screen Opiates TestDJG · Traditional | Amedica Biotech, Inc. | 11/06/2002SE |
| K020920 | Cozart Rapiscan Oral Fluid Drug Test - Opiate/MethadoneDJG · Traditional | Cozart Bioscience , Ltd. | 11/05/2002SE |
| K020368 | Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit)DJG · Traditional | Lin-Zhi International, Inc. | 06/04/2002SE |
| K020716 | Rapid Opiates Test Strip II, Rapid Opiates Test Card II and Doa Multiple Drug Test Cards…DJG · Traditional | Rapid Diagnostics, Inc. | 05/06/2002SE |
| K020371 | Uplink Test SystemDJG · Traditional | OraSure Technologies, Inc. | 04/03/2002SE |
| K014101 | Rapidone-Oxy TestDJG · Traditional | American Bio Medica Corp. | 03/20/2002SE |
| K013314 | OpiatesDJG · Traditional | Abbott Laboratories | 03/13/2002SE |
| K013482 | Abuscreen Online Opiates 300 / 2000DJG · Traditional | Roche Diagnostics Corp. | 12/21/2001SE |
| K013380 | Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test DeviceDJG · Traditional | ACON Laboratories, Inc. | 12/18/2001SE |
| K013408 | At Home Drug Test, Model 9079DJG · Special | Phamatech, Inc. | 12/06/2001SE |
| K013407 | At Home Drug Test, Model 9084DJG · Special | Phamatech, Inc. | 12/06/2001SE |
| K012483 | Ameditech Immutest Drug Screen OpiatesDJG · Traditional | Ameditech, Inc. | 11/30/2001SE |
| K011353 | Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test DeviceDJG · Traditional | ACON Laboratories, Inc. | 07/30/2001SE |
| K011150 | Dridau Opiate AssayDJG · Traditional | Microgenics Corp. | 06/20/2001SE |
| K011289 | Emit II Plus Opiate Assay, Model OSR9B229DJG · Special | Syva Co., Dade Behring, Inc. | 05/15/2001SE |
| K000851 | Psychemedics Analysis of Morphine in HairDJG · Traditional | Psychemedics Corp. | 12/11/2000SE |
| K003209 | Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. DF93ADJG · Traditional | Dade Behring, Inc. | 12/05/2000SE |
| K002268 | Branan Medical Corporation Monitect Morphine 2000 Drug Screen TestDJG · Traditional | Branan Medical Corporation | 11/27/2000SE |
| K001178 | Cedia Dau 6-ACETYLMORPHINE AssayDJG · Traditional | Microgenics Corp. | 06/09/2000SE |
| K000464 | Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. DF 90ADJG · Traditional | Dade Behring, Inc. | 04/14/2000SE |
| K000273 | Screeners Opiates Test Drugscreen Dip Opiates TestDJG · Traditional | Drug Detection Devices, Ltd. | 04/07/2000SE |
| K993151 | Radid Drug Screen 5-PANEL TestDJG · Traditional | American Bio Medica Corp. | 01/10/2000SE |
| K994234 | At Home Drug Test, Model 9083DJG · Special | Phamatech | 12/30/1999SE |
| K992111 | Verdict -Ii Opiates 2000DJG · Traditional | Medtox Diagnostics, Inc. | 12/16/1999SE |
| K992890 | Roche Cobas Integra Opiates 300/2000DJG · Traditional | Roche Diagnostics Corp. | 11/23/1999SE |
| K993491 | Quickpac II One Step Opiates TestDJG · Traditional | Syntron Bioresearch, Inc. | 10/29/1999SE |
| K993490 | Quickstrip One Step Opiates TestDJG · Traditional | Syntron Bioresearch, Inc. | 10/29/1999SE |
| K993165 | Quickscreen Pro Multi Drug Screen, Model 9177 & 9178DJG · Special | Phamatech | 10/20/1999SE |
| K991883 | Redi-Test OpiatesDJG · Traditional | Advantage Diagnostics Corp. | 09/15/1999SE |
| K992422 | Accusign DOA3,DOA, COC/THC/OPI2000 DOA3; Biosign DOA3, COC/THC/OPI2000; Status DS…DJG · Special | Princeton BioMeditech Corp. | 08/10/1999SE |
| K990820 | Rapidone - Opiates TestDJG · Traditional | American Bio Medica Corp. | 07/15/1999SE |
| K984152 | Synchron Systems Opiates 2000 NG (OP2) ReagentDJG · Traditional | Beckman Coulter, Inc. | 01/29/1999SE |
| K984232 | Modification of Emit D.A.U. Opiates AssayDJG · Traditional | Syva Co. | 01/22/1999SE |
| K983190 | Dbest Opiates Test KitDJG · Traditional | Ameritek, Inc. | 11/18/1998SE |
| K981771 | Accusign Mop, Biosign Mop, Staus DS MopDJG · Traditional | Princeton BioMeditech Corp. | 06/12/1998SE |
| K981341 | STC Opiates Micro-Plate Eia (Orasure Application)DJG · Traditional | OraSure Technologies, Inc. | 05/22/1998SE |
| K974840 | Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack…DJG · Traditional | Roche Diagnostic Systems, Inc. | 04/24/1998SE |
| K973761 | Micro-Strip for Opiate MetabolitesDJG · Traditional | Microdiagnostics, Inc. | 12/24/1997SE |
| K973156 | Ubi Magiwel Cocaine MetabolitesDJG · Traditional | United Biotech, Inc. | 10/28/1997SE |
| K973155 | Ubi Magiwel Opiate MetabolitesDJG · Traditional | United Biotech, Inc. | 10/28/1997SE |
| K973153 | Ubi Magiwel Amphetamine MetabolitesDJG · Traditional | United Biotech, Inc. | 10/28/1997SE |
| K972619 | Quickscreen One Step Opiate Screening Test (9080)DJG · Traditional | Phamatech | 08/20/1997SE |
| K972571 | Quikstrip One Step Opiates TestDJG · Traditional | Drial Consultants, Inc. | 08/20/1997SE |
| K972405 | Quikpac II One Step Opiate TestDJG · Traditional | Drial Consultants, Inc. | 08/08/1997SE |
| K971596 | Emit II Opiates 300/2000 AssayDJG · Traditional | Behring Diagnostics, Inc. | 06/25/1997SE |
| K971361 | Aq Opiates (Morphine) TestDJG · Traditional | Bionike Laboratories, Inc. | 06/06/1997SE |
| K962323 | Immulite Opiates Screen/Control ModuleDJG · Traditional | Diagnostic Products Corp. | 03/10/1997SE |
| K962795 | Cedia Dau Opiate 2K AssayDJG · Traditional | Boehringer Mannheim Corp. | 10/30/1996SE |
| K954498 | Frontline OpiatesDJG · Traditional | Boehringer Mannheim Corp. | 03/06/1996SE |
| K952096 | One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine)DJG · Traditional | Tcpi, Inc. | 08/17/1995SE |
| K935565 | Opiates Micro-Plate AssayDJG · Traditional | Solarcare Technologies Corp,Inc. | 07/14/1995SE |
| K951287 | Axsym OpiatesDJG · Traditional | Abbott Laboratories | 05/18/1995SE |
| K950136 | Urine Opiates Screen Flex(Tm) Reagent CartridgeDJG · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/05/1995SE |
| K945608 | Abusign(Tm) Opi, Doa-Opi, Accusign(Tm) Opi, Doa-Opi, Biosign(Tm) Opi, Doa-OpiDJG · Traditional | Princeton BioMeditech Corp. | 02/10/1995SE |
| K943248 | Visualine II Morphine/Opiates/HeroinDJG · Traditional | Sun Biomedical Laboratories, Inc. | 01/30/1995SE |
| K945343 | Cedia Dau Opiate AssayDJG · Traditional | Microgenics Corp. | 01/17/1995SE |
| K944606 | CX Opiate Reagent for Synchron CX SystemsDJG · Traditional | Beckman-Diagnostic Systems Group | 11/30/1994SE |
| K943712 | Verdict OpiatesDJG · Traditional | Editek, Inc. | 11/17/1994SE |
| K941041 | Solor Care Technologies Corporation OpiatesDJG · Traditional | Solar Technologies Corp. | 11/02/1994SE |
| K941195 | Cedia Dau Opiate AssayDJG · Traditional | Microgenics Corp. | 09/07/1994SE |
| K935346 | Cedia(R) Dau Opiate AssayDJG · Traditional | Microgenics Corp. | 01/11/1994SE |
| K935117 | Emit(R) Iic Opiate AssayDJG · Traditional | Syva Co. | 01/06/1994SE |
| K932318 | Usdt Opiate Assay Column Catalog No. 9000-200DJG · Traditional | U.S. Drug Testing, Inc. | 06/15/1993SE |
| K924446 | Micro-Plate Opiates AssayDJG · Traditional | Solarcare Technologies Corp,Inc. | 10/15/1992SE |
| K923468 | Micro Eia for Opiate MetabolitesDJG · Traditional | Microdiagnostics, Inc. | 09/15/1992SE |
| K921328 | STC Diagnostics Auto-Lyte Opiate EiaDJG · Traditional | Solarcare Technologies Corp,Inc. | 08/20/1992SE |
| K915180 | Opiate Eia AssayDJG · Traditional | Diagnostic Reagents, Inc. | 01/22/1992SE |
| K913742 | Il Test(Tm) OpiateDJG · Traditional | Instrumentation Laboratory CO | 11/07/1991SE |
| K913863 | Urine Heroin/Morphine Direct Ria Kit (I-125)DJG · Traditional | Immunalysis Corporation | 09/19/1991SE |
| K905491 | Microline Screen for OpiatesDJG · Traditional | Drug Screening Systems, Inc. | 03/13/1991SE |
| K904997 | Abuscreen Online TM for OpiatesDJG · Traditional | Roche Diagnostic Systems, Inc. | 12/27/1990SE |
| K902924 | Biosite Diagnostics Opiate Screening TestDJG · Traditional | Biosite Incorporated | 09/14/1990SE |
| K902577 | Emit(R) II Opiate AssayDJG · Traditional | Syva Co. | 07/27/1990SE |
| K902194 | Micro Dau Opiate Enzyme Immunoassay KitDJG · Traditional | Immunotech Corp. | 07/17/1990SE |
| K901577 | Milenia(Tm) OpiatesDJG · Traditional | Diagnostic Products Corp. | 05/17/1990SE |
| K900173 | Hycor Accupinch Morphine TestDJG · Traditional | Hycor Biomedical, Inc. | 03/30/1990SE |
| K900203 | Ez-Screen:OpiatesDJG · Traditional | Environmental Diagnostics, Inc. | 03/09/1990SE |
| K890978 | Target Opiates-RDJG · Traditional | V-Tech, Inc. | 11/17/1989SE |
| K890979 | Target Opiates-VDJG · Traditional | V-Tech, Inc. | 10/04/1989SE |
| K891605 | Coat-A-Count(Tm) Fentanyl (TKFN1)DJG · Traditional | Diagnostic Products Corp. | 09/28/1989SE |
| K890888 | Abuscreen FP for MorphineDJG · Traditional | Roche Diagnostic Systems, Inc. | 03/15/1989SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0734-2026 Class II | Drug Test Small (4 substances)Distribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0733-2026 Class II | Illegally MarketedDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-2073-2025 Class II | VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP…Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected… | Ortho-Clinical Diagnostics, Inc. | 06/12/2025Open, Classified |
| Z-1743-2020 Class II | Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 ReagentLabeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove… | Carolina Liquid Chemistries Corp | 01/20/2020Terminated |
| Z-1752-2020 Class II | Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800…Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use.… | Beckman Coulter Inc. | 09/04/2019Terminated |
| Z-1751-2020 Class II | Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in…Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use.… | Beckman Coulter Inc. | 09/04/2019Terminated |
| Z-0692-2020 Class III | QuickTox 5 Panel Drug Screen DipCardMixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen… | Ameditech Inc | 02/15/2019Terminated |
| Z-1800-2018 Class III | Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440Incorrect calibrator level listed in qualitative calibration steps | Siemens Healthcare Diagnostics, Inc. | 03/12/2018Terminated |
| Z-1799-2018 Class III | Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483Incorrect calibrator level listed in qualitative calibration steps | Siemens Healthcare Diagnostics, Inc. | 03/12/2018Terminated |
| Z-1270-2014 Class III | Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in…Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality… | Lin-Zhi International Inc | 02/18/2014Terminated |
| Z-2053-2013 Class II | SARKEN STAT! 1- Panel Test Kit-OPI 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-2387-2011 | DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue…Express Diagnostics Int'l, Inc. has initiated a medical device recall on various model numbers of DrugCheck… | Express Diagnostics Int'l., Inc. | 03/18/2011Terminated |