Product Code: DJG
FDA class 2
21 CFR 862.3650
Enzyme Immunoassay, Opiates
Clinical Toxicology
The Enzyme Immunoassay for Opiates is a laboratory test using antibody-based enzyme immunoassay technology to screen for the presence of opiates in biological specimens, commonly employed in workplace drug testing, clinical toxicology, and emergency screening panels. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3650 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.
510(k)s
210
FEI Numbers
106
Registration Numbers
106
Unique Applicants
95
Years Active
41
Basic Information
- Product Code
- DJG
- Device Class
- FDA class 2
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 210 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Jun 18, 2025 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | Jun 14, 2024 | Substantially Equivalent | VivaChek Biotech (Hangzhou) Co., Ltd |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | May 10, 2024 | Substantially Equivalent | Guangzhou Decheng Biotechnology Co., Ltd. |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Mar 08, 2024 | Substantially Equivalent | Co-Innovation Biotech Co.,Ltd. |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card | Feb 23, 2024 | Substantially Equivalent | Shanghai Accurature Diagnostics Co., Ltd. |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | Jan 09, 2024 | Substantially Equivalent | Hangzhou Laihe Biotech Co., Ltd. |
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test | Dec 20, 2023 | Substantially Equivalent | Chemtron Biotech, Inc. |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Dec 13, 2023 | Substantially Equivalent | Guangzhou Decheng Biotechnology Co., Ltd. |
| K231752 | ARK Hydrocodone Assay | Nov 09, 2023 | Substantially Equivalent | ARK Diagnostics, Inc. |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Oct 05, 2023 | Substantially Equivalent | Randox Laboratories Limited |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Oct 05, 2023 | Substantially Equivalent | Randox Laboratories Limited |
| K231007 | CEDIA Heroin Metabolite (6-AM) Assay | Sep 27, 2023 | Substantially Equivalent | Microgenics Corporation |
| K231698 | AllTest Fentanyl Rapid Test (Urine) | Jul 31, 2023 | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. |
| K221605 | Emit® II Plus Buprenorphine Assay | Jul 25, 2023 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K230238 | BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | Mar 31, 2023 | Substantially Equivalent | Shenzhen Bioeasy Biotechnology Co.,Ltd. |
| K222955 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Feb 06, 2023 | Substantially Equivalent | Xenta Biomedical Science Co., Ltd. |
| K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 | Dec 13, 2022 | Substantially Equivalent | Shenzhen Superbio Technology Co.,Ltd. |
| K203527 | Immunalysis Tapentadol Urine HEIA | May 09, 2022 | Substantially Equivalent | lmmunalysis Corporation |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | Dec 22, 2021 | Substantially Equivalent | Immunalysis Corporation |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | Aug 12, 2021 | Substantially Equivalent | Assure Tech (Hangzhou) Co., Ltd. |
| K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair | Jul 27, 2021 | Substantially Equivalent | Psychemedics Corporation |
| K202007 | LZI Oxycodone III Enzyme Immunoassay | Sep 17, 2020 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K201494 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | Sep 17, 2020 | Substantially Equivalent | Advin Biotech, Inc. |
| K201938 | LZI Fentanyl II Enzyme Immunoassay | Aug 07, 2020 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K201223 | LZI Tramadol Enzyme Immunoassay | Jun 04, 2020 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K200197 | ARK Fentanyl II Assay | Feb 26, 2020 | Substantially Equivalent | ARK Diagnostics, Inc. |
| K192943 | CEDIA Heroin Metabolite (6-AM) assay | Dec 16, 2019 | Substantially Equivalent | Microgenics Corporation |
| K182103 | Psychemedics Microplate EIA for Fentanyl in Hair | Apr 18, 2019 | Substantially Equivalent | Psychemedics Corporation |
| K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | Mar 29, 2019 | Substantially Equivalent | Advin Biotech, Inc. |
| K182280 | ARK Tramadol Assay | Dec 10, 2018 | Substantially Equivalent | ARK Diagnostics, Inc. |
| K181159 | LZI Fentanyl Enzyme Immunoassay | Dec 03, 2018 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K180427 | ARK Fentanyl Assay | Jun 06, 2018 | Substantially Equivalent | ARK Diagnostics, Inc. |
| K172416 | Synermed Opiate Enzyme Immunoassay | Apr 19, 2018 | Substantially Equivalent | Infrared Laboratory Systems, LLC (dba Synermed) |
| K173195 | DRI Hydrocodone Assay | Feb 13, 2018 | Substantially Equivalent | Microgenics Corporation |
| K173183 | CEDIA Heroin Metabolite (6-AM) Assay | Nov 22, 2017 | Substantially Equivalent | Microgenics Corporation |
| K172910 | Emit II Plus Oxycodone Assay | Oct 18, 2017 | Substantially Equivalent | Siemens Healthcare Diagnostics Inc. |
| K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators | Jun 14, 2017 | Substantially Equivalent | IMMUNALYSIS CORPORATION |
| K163101 | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set | Apr 06, 2017 | Substantially Equivalent | MICROGENICS CORPORATION |
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | Apr 26, 2016 | Substantially Equivalent | Co-Innovation Biotech Co., Ltd |
| K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests | Apr 18, 2016 | Substantially Equivalent | Chemtron Biotech, Inc. |
| K152551 | First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test. | Nov 09, 2015 | Substantially Equivalent | W.H.P.M., INC. |
| K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive | Oct 23, 2015 | Substantially Equivalent | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls | Oct 09, 2015 | Substantially Equivalent | Microgenics Corporation |
| K151478 | Wondfo CR3 Keyless Split Sample Cup | Jul 01, 2015 | Substantially Equivalent | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls | May 20, 2015 | Substantially Equivalent | IMMUNALYSIS CORPORATION |
| K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 | Apr 17, 2015 | Substantially Equivalent | Chemtron Biotech, Inc. |
| K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls | Mar 09, 2015 | Substantially Equivalent | Immunalysis Corporation |
| K150179 | CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids | Feb 25, 2015 | Substantially Equivalent | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| K141205 | LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 | Feb 13, 2015 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K141803 | IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY | Feb 12, 2015 | Substantially Equivalent | Immunalysis Corporation |
| K143187 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) | Jan 27, 2015 | Substantially Equivalent | Healgen Scientific LLC |
| K140671 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE | Jan 08, 2015 | Substantially Equivalent | OMEGA LABORATORIES, INC. |
| K142280 | Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) | Oct 16, 2014 | Substantially Equivalent | HEALGEN SCIENTIFIC LLC |
| K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests | Oct 09, 2014 | Substantially Equivalent | Chemtron Biotech, Inc. |
| K140748 | ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD | Aug 20, 2014 | Substantially Equivalent | CO-INNOVATION BIOTECH CO.,LTD. |
| K141406 | IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS | Jul 01, 2014 | Substantially Equivalent | Immunalysis Corporation |
| K141055 | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) | Jun 13, 2014 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K140089 | CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) | Apr 08, 2014 | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. |
| K130650 | STATUS DS OXY | Feb 26, 2014 | Substantially Equivalent | PRINCETON BIOMEDITECH CORP. |
| K133642 | RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK | Jan 24, 2014 | Substantially Equivalent | BIOPHOR DIAGNOSTICS, INC. |
| K131168 | IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY | Jan 17, 2014 | Substantially Equivalent | Immunalysis Corporation |
| K130275 | QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST | Sep 26, 2013 | Substantially Equivalent | Tianjin New Bay Bioresearch Co., Ltd. |
| K122064 | FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE | May 07, 2013 | Substantially Equivalent | Tianjin New Bay Bioresearch Co., Ltd. |
| K130665 | WONDOFO MULTI-DRUG URINE TEST CUP / PANEL | Apr 09, 2013 | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. |
| K130055 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP | Feb 14, 2013 | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. |
| K123799 | PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR | Feb 08, 2013 | Substantially Equivalent | PSYCHEMEDICS CORP. |
| K113747 | RANDOX OPIATES ASSAY | Aug 24, 2012 | Substantially Equivalent | RANDOX LABORATORIES LIMITED |
| K120763 | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS | Jun 01, 2012 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K120761 | LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS | May 08, 2012 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K111926 | PSYCHEMEDICS OPIATES EIA | May 01, 2012 | Substantially Equivalent | PSYCHEMEDICS CORP. |
| K113624 | WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST | Mar 12, 2012 | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. |
| K103161 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES | Dec 13, 2011 | Substantially Equivalent | OMEGA LABORATORIES, INC. |
| K112310 | WONDFO METHADONE URINE TEST,OPIATE TEST | Sep 08, 2011 | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. |
| K110298 | OPIATE ENZYME IMMUNOASSAY | Jul 15, 2011 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K101754 | THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY | Apr 08, 2011 | Substantially Equivalent | MICROGENICS CORP. |
| K102779 | EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C | Mar 18, 2011 | Substantially Equivalent | Siemens Healthcare Diagnostics Inc. |
| K093867 | ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A | Feb 11, 2011 | Substantially Equivalent | Roche Diagnostics |
| K100951 | MEDTOX BUPRENORPHINE TEST | Oct 18, 2010 | Substantially Equivalent | MEDTOX DIAGNOSTICS, INC. |
| K093175 | WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES | Aug 25, 2010 | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. |
| K101195 | 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS | Jul 06, 2010 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K100051 | INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) | Jul 06, 2010 | Substantially Equivalent | ALFA SCIENTIFIC DESIGNS, INC. |
| K100023 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM | Apr 05, 2010 | Substantially Equivalent | MEDTOX DIAGNOSTICS, INC. |
| K091612 | UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; | Feb 24, 2010 | Substantially Equivalent | UCP BIOSCIENCES, INC. |
| K090844 | BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS | Jul 30, 2009 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K091454 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM | Jul 24, 2009 | Substantially Equivalent | MEDTOX DIAGNOSTICS, INC. |
| K081008 | BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS | Dec 22, 2008 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K082508 | FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD | Nov 21, 2008 | Substantially Equivalent | BRANAN MEDICAL CORPORATION |
| K063699 | IMDX SYSTEMS | Jun 01, 2007 | Substantially Equivalent | NOVX SYSTEMS INC. |
| K063545 | MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE | May 07, 2007 | Substantially Equivalent | ALFA SCIENTIFIC DESIGNS, INC. |
| K063015 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 | Dec 20, 2006 | Substantially Equivalent | AMEDITECH, INC. |
| K062460 | VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III | Dec 15, 2006 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K060760 | RAPIDONE-BUPRENORPHINE TEST | Aug 07, 2006 | Substantially Equivalent | AMERICAN BIO MEDICA CORP. |
| K060527 | INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST | Jul 25, 2006 | Substantially Equivalent | ALFA SCIENTIFIC DESIGNS, INC. |
| K051958 | MP RAPIDOXY TEST STRIP, MODEL 07RD-7073 | Jul 21, 2006 | Substantially Equivalent | MP BIOMEDICALS, LLC. |
| K053037 | ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 | Jun 15, 2006 | Substantially Equivalent | ACRO BIOTECH LLC. |
| K060351 | MEDTOX OXYCODONE | May 12, 2006 | Substantially Equivalent | MEDTOX DIAGNOSTICS, INC. |
| K052520 | RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC | Apr 24, 2006 | Substantially Equivalent | Tianjin New Bay Bioresearch Co., Ltd. |
| K060466 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE | Apr 21, 2006 | Substantially Equivalent | ACON LABORATORIES, INC. |
| K051626 | IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS | Oct 13, 2005 | Substantially Equivalent | Immunalysis Corporation |
| K042725 | QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) | Jul 06, 2005 | Substantially Equivalent | QUEST DIAGNOSTICS, INC. |
| K050733 | OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS | Jun 13, 2005 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K042988 | RAPID ONE STEP BUPRENORPHINE TEST CARD | May 12, 2005 | Substantially Equivalent | Tianjin New Bay Bioresearch Co., Ltd. |
| K042990 | FOR SURE ONE STEP BUPRENORPHINE TEST STRIP | May 10, 2005 | Substantially Equivalent | Tianjin New Bay Bioresearch Co., Ltd. |
| K043507 | ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE | Feb 25, 2005 | Substantially Equivalent | ACON LABORATORIES, INC. |
| K043051 | QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 | Feb 07, 2005 | Substantially Equivalent | PHAMATECH INC. |
| K041747 | IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) | Nov 24, 2004 | Substantially Equivalent | LIFEPOINT,INC |
| K041746 | IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) | Nov 23, 2004 | Substantially Equivalent | LIFEPOINT,INC |
| K041144 | RANDOX OPIATES ASSAY | Nov 03, 2004 | Substantially Equivalent | RANDOX LABORATORIES, LTD. |
| K040316 | CEDIA BUPRENORPHINE ASSAY | Jun 23, 2004 | Substantially Equivalent | MICROGENICS CORP. |
| K040274 | ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE | May 03, 2004 | Substantially Equivalent | ACON LABORATORIES, INC. |
| K033047 | ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE | Feb 17, 2004 | Substantially Equivalent | ACON LABORATORIES, INC. |
| K031032 | VERDICT II, PROFILE II | Jul 14, 2003 | Substantially Equivalent | MEDTOX DIAGNOSTICS, INC. |
| K030113 | MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 | Jul 02, 2003 | Substantially Equivalent | BRANAN MEDICAL CORP. |
| K031002 | SYNCHRON SYSTEMS OPIATE REAGENT | Apr 29, 2003 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K023047 | AMEDICA DRUG SCREEN OPIATES TEST | Nov 06, 2002 | Substantially Equivalent | AMEDICA BIOTECH, INC. |
| K020920 | COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE | Nov 05, 2002 | Substantially Equivalent | COZART BIOSCIENCE LTD. |
| K020368 | OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) | Jun 04, 2002 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K020716 | RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS) | May 06, 2002 | Substantially Equivalent | RAPID DIAGNOSTICS, INC. |
| K020371 | UPLINK TEST SYSTEM | Apr 03, 2002 | Substantially Equivalent | ORASURE TECHNOLOGIES, INC. |
| K014101 | RAPIDONE-OXY TEST | Mar 20, 2002 | Substantially Equivalent | AMERICAN BIO MEDICA CORP. |
| K013314 | OPIATES | Mar 13, 2002 | Substantially Equivalent | ABBOTT LABORATORIES |
| K013482 | ABUSCREEN ONLINE OPIATES 300 / 2000 | Dec 21, 2001 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K013380 | ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE | Dec 18, 2001 | Substantially Equivalent | ACON LABORATORIES, INC. |
| K013408 | AT HOME DRUG TEST, MODEL 9079 | Dec 06, 2001 | Substantially Equivalent | PHAMATECH INC. |
| K013407 | AT HOME DRUG TEST, MODEL 9084 | Dec 06, 2001 | Substantially Equivalent | PHAMATECH INC. |
| K012483 | AMEDITECH IMMUTEST DRUG SCREEN OPIATES | Nov 30, 2001 | Substantially Equivalent | AMEDITECH, INC. |
| K011353 | ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE | Jul 30, 2001 | Substantially Equivalent | ACON LABORATORIES, INC. |
| K011150 | DRIDAU OPIATE ASSAY | Jun 20, 2001 | Substantially Equivalent | MICROGENICS CORP. |
| K011289 | EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 | May 15, 2001 | Substantially Equivalent | SYVA CO., DADE BEHRING, INC. |
| K000851 | PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR | Dec 11, 2000 | Substantially Equivalent | PSYCHEMEDICS CORP. |
| K003209 | URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A | Dec 05, 2000 | Substantially Equivalent | DADE BEHRING, INC. |
| K002268 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST | Nov 27, 2000 | Substantially Equivalent | BRANAN MEDICAL CORPORATION |
| K001178 | CEDIA DAU 6-ACETYLMORPHINE ASSAY | Jun 09, 2000 | Substantially Equivalent | MICROGENICS CORP. |
| K000464 | URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A | Apr 14, 2000 | Substantially Equivalent | DADE BEHRING, INC. |
| K000273 | SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST | Apr 07, 2000 | Substantially Equivalent | DRUG DETECTION DEVICES, LTD. |
| K993151 | RADID DRUG SCREEN 5-PANEL TEST | Jan 10, 2000 | Substantially Equivalent | AMERICAN BIO MEDICA CORP. |
| K994234 | AT HOME DRUG TEST, MODEL 9083 | Dec 30, 1999 | Substantially Equivalent | PHAMATECH |
| K992111 | VERDICT -II OPIATES 2000 | Dec 16, 1999 | Substantially Equivalent | MEDTOX DIAGNOSTICS, INC. |
| K992890 | ROCHE COBAS INTEGRA OPIATES 300/2000 | Nov 23, 1999 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K993491 | QUICKPAC II ONE STEP OPIATES TEST | Oct 29, 1999 | Substantially Equivalent | SYNTRON BIORESEARCH, INC. |
| K993490 | QUICKSTRIP ONE STEP OPIATES TEST | Oct 29, 1999 | Substantially Equivalent | SYNTRON BIORESEARCH, INC. |
| K993165 | QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 | Oct 20, 1999 | Substantially Equivalent | PHAMATECH |
| K991883 | REDI-TEST OPIATES | Sep 15, 1999 | Substantially Equivalent | ADVANTAGE DIAGNOSTICS CORP. |
| K992422 | ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 | Aug 10, 1999 | Substantially Equivalent | PRINCETON BIOMEDITECH CORP. |
| K990820 | RAPIDONE - OPIATES TEST | Jul 15, 1999 | Substantially Equivalent | AMERICAN BIO MEDICA CORP. |
| K984152 | SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT | Jan 29, 1999 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K984232 | MODIFICATION OF EMIT D.A.U. OPIATES ASSAY | Jan 22, 1999 | Substantially Equivalent | SYVA CO. |
| K983190 | DBEST OPIATES TEST KIT | Nov 18, 1998 | Substantially Equivalent | AMERITEK, INC. |
| K981771 | ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP | Jun 12, 1998 | Substantially Equivalent | PRINCETON BIOMEDITECH CORP. |
| K981341 | STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) | May 22, 1998 | Substantially Equivalent | ORASURE TECHNOLOGIES, INC. |
| K974840 | ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL | Apr 24, 1998 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K973761 | MICRO-STRIP FOR OPIATE METABOLITES | Dec 24, 1997 | Substantially Equivalent | MICRODIAGNOSTICS, INC. |
| K973156 | UBI MAGIWEL COCAINE METABOLITES | Oct 28, 1997 | Substantially Equivalent | UNITED BIOTECH, INC. |
| K973155 | UBI MAGIWEL OPIATE METABOLITES | Oct 28, 1997 | Substantially Equivalent | UNITED BIOTECH, INC. |
| K973153 | UBI MAGIWEL AMPHETAMINE METABOLITES | Oct 28, 1997 | Substantially Equivalent | UNITED BIOTECH, INC. |
| K972619 | QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) | Aug 20, 1997 | Substantially Equivalent | PHAMATECH |
| K972571 | QUIKSTRIP ONE STEP OPIATES TEST | Aug 20, 1997 | Substantially Equivalent | DRIAL CONSULTANTS, INC. |
| K972405 | QUIKPAC II ONE STEP OPIATE TEST | Aug 08, 1997 | Substantially Equivalent | DRIAL CONSULTANTS, INC. |
| K971596 | EMIT II OPIATES 300/2000 ASSAY | Jun 25, 1997 | Substantially Equivalent | BEHRING DIAGNOSTICS, INC. |
| K971361 | AQ OPIATES (MORPHINE) TEST | Jun 06, 1997 | Substantially Equivalent | BIONIKE LABORATORIES, INC. |
| K962323 | IMMULITE OPIATES SCREEN/CONTROL MODULE | Mar 10, 1997 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K962795 | CEDIA DAU OPIATE 2K ASSAY | Oct 30, 1996 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K954498 | FRONTLINE OPIATES | Mar 06, 1996 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K952096 | ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) | Aug 17, 1995 | Substantially Equivalent | TCPI, INC. |
| K935565 | OPIATES MICRO-PLATE ASSAY | Jul 14, 1995 | Substantially Equivalent | SOLARCARE TECHNOLOGIES CORP,INC. |
| K951287 | AXSYM OPIATES | May 18, 1995 | Substantially Equivalent | ABBOTT LABORATORIES |
| K950136 | URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE | Apr 05, 1995 | Substantially Equivalent | E.I. DUPONT DE NEMOURS & CO., INC. |
| K945608 | ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI | Feb 10, 1995 | Substantially Equivalent | PRINCETON BIOMEDITECH CORP. |
| K943248 | VISUALINE II MORPHINE/OPIATES/HEROIN | Jan 30, 1995 | Substantially Equivalent | SUN BIOMEDICAL LABORATORIES, INC. |
| K945343 | CEDIA DAU OPIATE ASSAY | Jan 17, 1995 | Substantially Equivalent | MICROGENICS CORP. |
| K944606 | CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS | Nov 30, 1994 | Substantially Equivalent | BECKMAN-DIAGNOSTIC SYSTEMS GROUP |
| K943712 | VERDICT OPIATES | Nov 17, 1994 | Substantially Equivalent | EDITEK, INC. |
| K941041 | SOLOR CARE TECHNOLOGIES CORPORATION OPIATES | Nov 02, 1994 | Substantially Equivalent | SOLAR TECHNOLOGIES CORP. |
| K941195 | CEDIA DAU OPIATE ASSAY | Sep 07, 1994 | Substantially Equivalent | MICROGENICS CORP. |
| K935346 | CEDIA(R) DAU OPIATE ASSAY | Jan 11, 1994 | Substantially Equivalent | MICROGENICS CORP. |
| K935117 | EMIT(R) IIC OPIATE ASSAY | Jan 06, 1994 | Substantially Equivalent | SYVA CO. |
| K932318 | USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 | Jun 15, 1993 | Substantially Equivalent | U.S. DRUG TESTING, INC. |
| K924446 | MICRO-PLATE OPIATES ASSAY | Oct 15, 1992 | Substantially Equivalent | SOLARCARE TECHNOLOGIES CORP,INC. |
| K923468 | MICRO EIA FOR OPIATE METABOLITES | Sep 15, 1992 | Substantially Equivalent | MICRODIAGNOSTICS, INC. |
| K921328 | STC DIAGNOSTICS AUTO-LYTE OPIATE EIA | Aug 20, 1992 | Substantially Equivalent | SOLARCARE TECHNOLOGIES CORP,INC. |
| K915180 | OPIATE EIA ASSAY | Jan 22, 1992 | Substantially Equivalent | DIAGNOSTIC REAGENTS, INC. |
| K913742 | IL TEST(TM) OPIATE | Nov 07, 1991 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K913863 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) | Sep 19, 1991 | Substantially Equivalent | Immunalysis Corporation |
| K905491 | MICROLINE SCREEN FOR OPIATES | Mar 13, 1991 | Substantially Equivalent | DRUG SCREENING SYSTEMS, INC. |
| K904997 | ABUSCREEN ONLINE TM FOR OPIATES | Dec 27, 1990 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K902924 | BIOSITE DIAGNOSTICS OPIATE SCREENING TEST | Sep 14, 1990 | Substantially Equivalent | BIOSITE INCORPORATED |
| K902577 | EMIT(R) II OPIATE ASSAY | Jul 27, 1990 | Substantially Equivalent | SYVA CO. |
| K902194 | MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT | Jul 17, 1990 | Substantially Equivalent | IMMUNOTECH CORP. |
| K901577 | MILENIA(TM) OPIATES | May 17, 1990 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K900173 | HYCOR ACCUPINCH MORPHINE TEST | Mar 30, 1990 | Substantially Equivalent | HYCOR BIOMEDICAL, INC. |
| K900203 | EZ-SCREEN:OPIATES | Mar 09, 1990 | Substantially Equivalent | ENVIRONMENTAL DIAGNOSTICS, INC. |
| K890978 | TARGET OPIATES-R | Nov 17, 1989 | Substantially Equivalent | V-TECH, INC. |
| K890979 | TARGET OPIATES-V | Oct 04, 1989 | Substantially Equivalent | V-TECH, INC. |
| K891605 | COAT-A-COUNT(TM) FENTANYL (TKFN1) | Sep 28, 1989 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K890888 | ABUSCREEN FP FOR MORPHINE | Mar 15, 1989 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K882496 | ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE | Sep 02, 1988 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K881941 | EMIT HVA OPIATE ASSAY | Aug 02, 1988 | Substantially Equivalent | SYVA CO. |
| K874808 | COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 | Feb 18, 1988 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K880010 | REVISED LABELING FOR ADX OPIATES | Feb 11, 1988 | Substantially Equivalent | ABBOTT LABORATORIES |
| K874485 | REVISED LABELING FOR OPIATES | Nov 23, 1987 | Substantially Equivalent | ABBOTT LABORATORIES |
| K874268 | REVISED LABELING FOR MORPHINE TEST KIT | Nov 13, 1987 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K873898 | REVISED LABELING FOR SYVA OPIATE ASSAYS | Oct 29, 1987 | Substantially Equivalent | SYVA CO. |
| K873758 | LABELING CHANGE COAT-A-COUNT SERUM MORPHINE | Oct 15, 1987 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K873757 | LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE | Oct 15, 1987 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K872391 | ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD | Aug 10, 1987 | Substantially Equivalent | E.I. DUPONT DE NEMOURS & CO., INC. |
| K871698 | RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] | Jun 15, 1987 | Substantially Equivalent | Immunalysis Corporation |
| K854421 | TDX R OPIATES | Nov 25, 1985 | Substantially Equivalent | ABBOTT LABORATORIES |
| K842677 | EMIT D.A.U. OPIATE ASSAY | Sep 26, 1984 | Substantially Equivalent | SYVA CO. |
| K843162 | EMIT 700 OPIATE ASSAY | Sep 14, 1984 | Substantially Equivalent | SYVA CO. |
| K833581 | MODIF. OF EMIT URINE OPIATE ASSAY | Jan 26, 1984 | Substantially Equivalent | SYVA CO. |
FEI Numbers
This FDA classification entry is associated with 106 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 106 registration numbers. Click on an entry to view related FDA registrations.