FDA 510(k) Applications for Medical Device Product Code "DJG"
(Enzyme Immunoassay, Opiates)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K013314 | ABBOTT LABORATORIES | OPIATES | 03/13/2002 |
| 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 |
| K201494 | Advin Biotech, Inc. | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | 09/17/2020 |
| K182123 | Advin Biotech, Inc. | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | 03/29/2019 |
| 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 |
| K200197 | ARK Diagnostics, Inc. | ARK Fentanyl II Assay | 02/26/2020 |
| K182280 | ARK Diagnostics, Inc. | ARK Tramadol Assay | 12/10/2018 |
| K201630 | Assure Tech (Hangzhou) Co., Ltd. | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | 08/12/2021 |
| 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 |
| 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 |
| 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 |
| K962323 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE OPIATES SCREEN/CONTROL MODULE | 03/10/1997 |
| 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 |
| 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 |
| K231698 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Fentanyl Rapid Test (Urine) | 07/31/2023 |
| 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 |
| 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 |
| K203564 | Immunalysis Corporation | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | 12/22/2021 |
| K172416 | Infrared Laboratory Systems, LLC (dba Synermed) | Synermed Opiate Enzyme Immunoassay | 04/19/2018 |
| 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 |
| K181159 | Lin-Zhi International, Inc. | LZI Fentanyl Enzyme Immunoassay | 12/03/2018 |
| K201938 | Lin-Zhi International, Inc. | LZI Fentanyl II Enzyme Immunoassay | 08/07/2020 |
| 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 |
| K202007 | Lin-Zhi International, Inc. | LZI Oxycodone III Enzyme Immunoassay | 09/17/2020 |
| K201223 | Lin-Zhi International, Inc. | LZI Tramadol Enzyme Immunoassay | 06/04/2020 |
| 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 |
| K203527 | lmmunalysis Corporation | Immunalysis Tapentadol Urine HEIA | 05/09/2022 |
| 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 |
| 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 |
| 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 |
| K192943 | Microgenics Corporation | CEDIA Heroin Metabolite (6-AM) assay | 12/16/2019 |
| K231007 | Microgenics Corporation | CEDIA Heroin Metabolite (6-AM) Assay | 09/27/2023 |
| 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 |
| 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 |
| K201326 | Psychemedics Corporation | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair | 07/27/2021 |
| K182103 | Psychemedics Corporation | Psychemedics Microplate EIA for Fentanyl in Hair | 04/18/2019 |
| K042725 | QUEST DIAGNOSTICS, INC. | QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) | 07/06/2005 |
| K221550 | Randox Laboratories Limited | Evidence MultiSTAT DOA Urine MultiPlex | 10/05/2023 |
| K220451 | Randox Laboratories Limited | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | 10/05/2023 |
| 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 |
| K974840 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL | 04/24/1998 |
| 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 |
| K230238 | Shenzhen Bioeasy Biotechnology Co.,Ltd. | BIOEASYÖ U-Catch MAX Multi-Drug Test Cup, BIOEASYÖ U-Catch MAX Multi-Drug Test Cup Rx | 03/31/2023 |
| K220046 | Shenzhen Superbio Technology Co.,Ltd. | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 | 12/13/2022 |
| 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 |
| K221605 | Siemens Healthcare Diagnostics, Inc. | Emit« II Plus Buprenorphine Assay | 07/25/2023 |
| 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 |
| K984232 | SYVA CO. | MODIFICATION OF EMIT D.A.U. OPIATES ASSAY | 01/22/1999 |
| K011289 | SYVA CO., DADE BEHRING, INC. | EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 | 05/15/2001 |
| 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 |
| 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 |
| 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 |
| K222955 | Xenta Biomedical Science Co., Ltd. | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | 02/06/2023 |
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