FDA 510(k) Applications for Medical Device Product Code "DJG"
(Enzyme Immunoassay, Opiates)

FDA 510(k) Number Applicant Device Name Decision Date
K951287 ABBOTT LABORATORIES AXSYM OPIATES 05/18/1995
K013314 ABBOTT LABORATORIES OPIATES 03/13/2002
K880010 ABBOTT LABORATORIES REVISED LABELING FOR ADX OPIATES 02/11/1988
K874485 ABBOTT LABORATORIES REVISED LABELING FOR OPIATES 11/23/1987
K854421 ABBOTT LABORATORIES TDX R OPIATES 11/25/1985
K060466 ACON LABORATORIES, INC. ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE 04/21/2006
K013380 ACON LABORATORIES, INC. ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE 12/18/2001
K040274 ACON LABORATORIES, INC. ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE 05/03/2004
K011353 ACON LABORATORIES, INC. ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE 07/30/2001
K043507 ACON LABORATORIES, INC. ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE 02/25/2005
K033047 ACON LABORATORIES, INC. ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE 02/17/2004
K053037 ACRO BIOTECH LLC. ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 06/15/2006
K991883 ADVANTAGE DIAGNOSTICS CORP. REDI-TEST OPIATES 09/15/1999
K060527 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST 07/25/2006
K100051 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) 07/06/2010
K063545 ALFA SCIENTIFIC DESIGNS, INC. MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE 05/07/2007
K023047 AMEDICA BIOTECH, INC. AMEDICA DRUG SCREEN OPIATES TEST 11/06/2002
K012483 AMEDITECH, INC. AMEDITECH IMMUTEST DRUG SCREEN OPIATES 11/30/2001
K063015 AMEDITECH, INC. AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 12/20/2006
K993151 AMERICAN BIO MEDICA CORP. RADID DRUG SCREEN 5-PANEL TEST 01/10/2000
K990820 AMERICAN BIO MEDICA CORP. RAPIDONE - OPIATES TEST 07/15/1999
K060760 AMERICAN BIO MEDICA CORP. RAPIDONE-BUPRENORPHINE TEST 08/07/2006
K014101 AMERICAN BIO MEDICA CORP. RAPIDONE-OXY TEST 03/20/2002
K983190 AMERITEK, INC. DBEST OPIATES TEST KIT 11/18/1998
K180427 ARK Diagnostics, Inc. ARK Fentanyl Assay 06/06/2018
K031002 BECKMAN COULTER, INC. SYNCHRON SYSTEMS OPIATE REAGENT 04/29/2003
K984152 BECKMAN COULTER, INC. SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT 01/29/1999
K944606 BECKMAN-DIAGNOSTIC SYSTEMS GROUP CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS 11/30/1994
K971596 BEHRING DIAGNOSTICS, INC. EMIT II OPIATES 300/2000 ASSAY 06/25/1997
K971361 BIONIKE LABORATORIES, INC. AQ OPIATES (MORPHINE) TEST 06/06/1997
K133642 BIOPHOR DIAGNOSTICS, INC. RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK 01/24/2014
K902924 BIOSITE INCORPORATED BIOSITE DIAGNOSTICS OPIATE SCREENING TEST 09/14/1990
K962795 BOEHRINGER MANNHEIM CORP. CEDIA DAU OPIATE 2K ASSAY 10/30/1996
K954498 BOEHRINGER MANNHEIM CORP. FRONTLINE OPIATES 03/06/1996
K030113 BRANAN MEDICAL CORP. MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 07/02/2003
K002268 BRANAN MEDICAL CORPORATION BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST 11/27/2000
K082508 BRANAN MEDICAL CORPORATION FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD 11/21/2008
K142396 Chemtron Biotech, Inc. Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests 10/09/2014
K143599 Chemtron Biotech, Inc. Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 04/17/2015
K153192 Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests 04/18/2016
K153050 Co-Innovation Biotech Co., Ltd Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard 04/26/2016
K140748 CO-INNOVATION BIOTECH CO.,LTD. ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD 08/20/2014
K020920 COZART BIOSCIENCE LTD. COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE 11/05/2002
K000464 DADE BEHRING, INC. URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A 04/14/2000
K003209 DADE BEHRING, INC. URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A 12/05/2000
K874808 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 02/18/1988
K891605 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT(TM) FENTANYL (TKFN1) 09/28/1989
K962323 DIAGNOSTIC PRODUCTS CORP. IMMULITE OPIATES SCREEN/CONTROL MODULE 03/10/1997
K873757 DIAGNOSTIC PRODUCTS CORP. LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE 10/15/1987
K873758 DIAGNOSTIC PRODUCTS CORP. LABELING CHANGE COAT-A-COUNT SERUM MORPHINE 10/15/1987
K901577 DIAGNOSTIC PRODUCTS CORP. MILENIA(TM) OPIATES 05/17/1990
K915180 DIAGNOSTIC REAGENTS, INC. OPIATE EIA ASSAY 01/22/1992
K972405 DRIAL CONSULTANTS, INC. QUIKPAC II ONE STEP OPIATE TEST 08/08/1997
K972571 DRIAL CONSULTANTS, INC. QUIKSTRIP ONE STEP OPIATES TEST 08/20/1997
K000273 DRUG DETECTION DEVICES, LTD. SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST 04/07/2000
K905491 DRUG SCREENING SYSTEMS, INC. MICROLINE SCREEN FOR OPIATES 03/13/1991
K872391 E.I. DUPONT DE NEMOURS & CO., INC. ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD 08/10/1987
K950136 E.I. DUPONT DE NEMOURS & CO., INC. URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE 04/05/1995
K943712 EDITEK, INC. VERDICT OPIATES 11/17/1994
K900203 ENVIRONMENTAL DIAGNOSTICS, INC. EZ-SCREEN:OPIATES 03/09/1990
K130055 Guangzhou Wondfo Biotech Co., Ltd. ACON BUP ONE STEP BUPRENORPHINE TEST STRIP 02/14/2013
K150179 GUANGZHOU WONDFO BIOTECH CO., LTD. CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids 02/25/2015
K140089 Guangzhou Wondfo Biotech Co., Ltd. CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) 04/08/2014
K113624 Guangzhou Wondfo Biotech Co., Ltd. WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST 03/12/2012
K151478 GUANGZHOU WONDFO BIOTECH CO., LTD. Wondfo CR3 Keyless Split Sample Cup 07/01/2015
K112310 Guangzhou Wondfo Biotech Co., Ltd. WONDFO METHADONE URINE TEST,OPIATE TEST 09/08/2011
K093175 Guangzhou Wondfo Biotech Co., Ltd. WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES 08/25/2010
K130665 Guangzhou Wondfo Biotech Co., Ltd. WONDOFO MULTI-DRUG URINE TEST CUP / PANEL 04/09/2013
K143187 Healgen Scientific LLC Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) 01/27/2015
K142280 HEALGEN SCIENTIFIC LLC Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) 10/16/2014
K900173 HYCOR BIOMEDICAL, INC. HYCOR ACCUPINCH MORPHINE TEST 03/30/1990
K150275 Immunalysis Corporation Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls 03/09/2015
K141406 Immunalysis Corporation IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS 07/01/2014
K051626 Immunalysis Corporation IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS 10/13/2005
K143502 IMMUNALYSIS CORPORATION Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls 05/20/2015
K131168 Immunalysis Corporation IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY 01/17/2014
K161216 IMMUNALYSIS CORPORATION Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators 06/14/2017
K141803 Immunalysis Corporation IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY 02/12/2015
K871698 IMMUNALYSIS CORPORATION RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] 06/15/1987
K913863 IMMUNALYSIS CORPORATION URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) 09/19/1991
K902194 IMMUNOTECH CORP. MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT 07/17/1990
K172416 Infrared Laboratory Systems, LLC (dba Synermed) Synermed Opiate Enzyme Immunoassay 04/19/2018
K913742 INSTRUMENTATION LABORATORY CO. IL TEST(TM) OPIATE 11/07/1991
K041747 LIFEPOINT,INC IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) 11/24/2004
K041746 LIFEPOINT,INC IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) 11/23/2004
K101195 Lin-Zhi International, Inc. 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS 07/06/2010
K090844 Lin-Zhi International, Inc. BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS 07/30/2009
K081008 Lin-Zhi International, Inc. BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS 12/22/2008
K141055 Lin-Zhi International, Inc. LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) 06/13/2014
K120761 Lin-Zhi International, Inc. LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS 05/08/2012
K141205 Lin-Zhi International, Inc. LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 02/13/2015
K120763 Lin-Zhi International, Inc. LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS 06/01/2012
K110298 Lin-Zhi International, Inc. OPIATE ENZYME IMMUNOASSAY 07/15/2011
K020368 Lin-Zhi International, Inc. OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) 06/04/2002
K050733 Lin-Zhi International, Inc. OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS 06/13/2005
K100951 MEDTOX DIAGNOSTICS, INC. MEDTOX BUPRENORPHINE TEST 10/18/2010
K060351 MEDTOX DIAGNOSTICS, INC. MEDTOX OXYCODONE 05/12/2006
K091454 MEDTOX DIAGNOSTICS, INC. PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM 07/24/2009
K100023 MEDTOX DIAGNOSTICS, INC. PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM 04/05/2010
K992111 MEDTOX DIAGNOSTICS, INC. VERDICT -II OPIATES 2000 12/16/1999
K031032 MEDTOX DIAGNOSTICS, INC. VERDICT II, PROFILE II 07/14/2003
K923468 MICRODIAGNOSTICS, INC. MICRO EIA FOR OPIATE METABOLITES 09/15/1992
K973761 MICRODIAGNOSTICS, INC. MICRO-STRIP FOR OPIATE METABOLITES 12/24/1997
K040316 MICROGENICS CORP. CEDIA BUPRENORPHINE ASSAY 06/23/2004
K001178 MICROGENICS CORP. CEDIA DAU 6-ACETYLMORPHINE ASSAY 06/09/2000
K941195 MICROGENICS CORP. CEDIA DAU OPIATE ASSAY 09/07/1994
K945343 MICROGENICS CORP. CEDIA DAU OPIATE ASSAY 01/17/1995
K935346 MICROGENICS CORP. CEDIA(R) DAU OPIATE ASSAY 01/11/1994
K011150 MICROGENICS CORP. DRIDAU OPIATE ASSAY 06/20/2001
K101754 MICROGENICS CORP. THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY 04/08/2011
K163101 MICROGENICS CORPORATION CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set 04/06/2017
K173183 Microgenics Corporation CEDIA Heroin Metabolite (6-AM) Assay 11/22/2017
K173195 Microgenics Corporation DRI Hydrocodone Assay 02/13/2018
K150502 Microgenics Corporation DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls 10/09/2015
K051958 MP BIOMEDICALS, LLC. MP RAPIDOXY TEST STRIP, MODEL 07RD-7073 07/21/2006
K063699 NOVX SYSTEMS INC. IMDX SYSTEMS 06/01/2007
K103161 OMEGA LABORATORIES, INC. OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES 12/13/2011
K140671 OMEGA LABORATORIES, INC. OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE 01/08/2015
K981341 ORASURE TECHNOLOGIES, INC. STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) 05/22/1998
K020371 ORASURE TECHNOLOGIES, INC. UPLINK TEST SYSTEM 04/03/2002
K062460 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III 12/15/2006
K994234 PHAMATECH AT HOME DRUG TEST, MODEL 9083 12/30/1999
K972619 PHAMATECH QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) 08/20/1997
K993165 PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 10/20/1999
K013408 PHAMATECH INC. AT HOME DRUG TEST, MODEL 9079 12/06/2001
K013407 PHAMATECH INC. AT HOME DRUG TEST, MODEL 9084 12/06/2001
K043051 PHAMATECH INC. QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 02/07/2005
K945608 PRINCETON BIOMEDITECH CORP. ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI 02/10/1995
K992422 PRINCETON BIOMEDITECH CORP. ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 08/10/1999
K981771 PRINCETON BIOMEDITECH CORP. ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP 06/12/1998
K130650 PRINCETON BIOMEDITECH CORP. STATUS DS OXY 02/26/2014
K000851 PSYCHEMEDICS CORP. PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR 12/11/2000
K123799 PSYCHEMEDICS CORP. PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR 02/08/2013
K111926 PSYCHEMEDICS CORP. PSYCHEMEDICS OPIATES EIA 05/01/2012
K042725 QUEST DIAGNOSTICS, INC. QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) 07/06/2005
K113747 RANDOX LABORATORIES LIMITED RANDOX OPIATES ASSAY 08/24/2012
K041144 RANDOX LABORATORIES, LTD. RANDOX OPIATES ASSAY 11/03/2004
K020716 RAPID DIAGNOSTICS, INC. RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS) 05/06/2002
K890888 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN FP FOR MORPHINE 03/15/1989
K974840 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL 04/24/1998
K904997 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE TM FOR OPIATES 12/27/1990
K882496 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE 09/02/1988
K874268 ROCHE DIAGNOSTIC SYSTEMS, INC. REVISED LABELING FOR MORPHINE TEST KIT 11/13/1987
K093867 Roche Diagnostics ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A 02/11/2011
K013482 ROCHE DIAGNOSTICS CORP. ABUSCREEN ONLINE OPIATES 300 / 2000 12/21/2001
K992890 ROCHE DIAGNOSTICS CORP. ROCHE COBAS INTEGRA OPIATES 300/2000 11/23/1999
K172910 Siemens Healthcare Diagnostics Inc. Emit II Plus Oxycodone Assay 10/18/2017
K102779 Siemens Healthcare Diagnostics Inc. EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C 03/18/2011
K150606 SIEMENS HEALTHCARE DIAGNOSTICS, INC. 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 10/23/2015
K941041 SOLAR TECHNOLOGIES CORP. SOLOR CARE TECHNOLOGIES CORPORATION OPIATES 11/02/1994
K924446 SOLARCARE TECHNOLOGIES CORP,INC. MICRO-PLATE OPIATES ASSAY 10/15/1992
K935565 SOLARCARE TECHNOLOGIES CORP,INC. OPIATES MICRO-PLATE ASSAY 07/14/1995
K921328 SOLARCARE TECHNOLOGIES CORP,INC. STC DIAGNOSTICS AUTO-LYTE OPIATE EIA 08/20/1992
K943248 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE II MORPHINE/OPIATES/HEROIN 01/30/1995
K993491 SYNTRON BIORESEARCH, INC. QUICKPAC II ONE STEP OPIATES TEST 10/29/1999
K993490 SYNTRON BIORESEARCH, INC. QUICKSTRIP ONE STEP OPIATES TEST 10/29/1999
K843162 SYVA CO. EMIT 700 OPIATE ASSAY 09/14/1984
K842677 SYVA CO. EMIT D.A.U. OPIATE ASSAY 09/26/1984
K881941 SYVA CO. EMIT HVA OPIATE ASSAY 08/02/1988
K902577 SYVA CO. EMIT(R) II OPIATE ASSAY 07/27/1990
K935117 SYVA CO. EMIT(R) IIC OPIATE ASSAY 01/06/1994
K833581 SYVA CO. MODIF. OF EMIT URINE OPIATE ASSAY 01/26/1984
K984232 SYVA CO. MODIFICATION OF EMIT D.A.U. OPIATES ASSAY 01/22/1999
K873898 SYVA CO. REVISED LABELING FOR SYVA OPIATE ASSAYS 10/29/1987
K011289 SYVA CO., DADE BEHRING, INC. EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 05/15/2001
K952096 TCPI, INC. ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) 08/17/1995
K042990 Tianjin New Bay Bioresearch Co., Ltd. FOR SURE ONE STEP BUPRENORPHINE TEST STRIP 05/10/2005
K122064 Tianjin New Bay Bioresearch Co., Ltd. FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE 05/07/2013
K130275 Tianjin New Bay Bioresearch Co., Ltd. QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST 09/26/2013
K052520 Tianjin New Bay Bioresearch Co., Ltd. RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC 04/24/2006
K042988 Tianjin New Bay Bioresearch Co., Ltd. RAPID ONE STEP BUPRENORPHINE TEST CARD 05/12/2005
K932318 U.S. DRUG TESTING, INC. USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 06/15/1993
K091612 UCP BIOSCIENCES, INC. UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; 02/24/2010
K973153 UNITED BIOTECH, INC. UBI MAGIWEL AMPHETAMINE METABOLITES 10/28/1997
K973156 UNITED BIOTECH, INC. UBI MAGIWEL COCAINE METABOLITES 10/28/1997
K973155 UNITED BIOTECH, INC. UBI MAGIWEL OPIATE METABOLITES 10/28/1997
K890978 V-TECH, INC. TARGET OPIATES-R 11/17/1989
K890979 V-TECH, INC. TARGET OPIATES-V 10/04/1989
K152551 W.H.P.M., INC. 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 11/09/2015


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