Panels › Clinical Toxicology › Product code DJR · Class 2
Enzyme Immunoassay, Methadone
Regulation 862.3620
0510(k)s in 12 months (63 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in DJR
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 4, 2019 | K192433 | LZI Methadone II Enzyme Immunoassay Lin-Zhi International, Inc. | DJR |
| Nov 21, 2018 | K182779 | ARK EDDP Assay Ark Diagnostics, Inc. | DJR |
| Jun 26, 2017 | K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators Lin-Zhi International, Inc. | DJR |
| Aug 17, 2016 | K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortr W.H.P.M., Inc. | DJR |
| Oct 5, 2015 | K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Pan Assure Tech. Co., Ltd., CN | DJR |
| Jul 24, 2015 | K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control S Immunalysis Corporation | DJR |
| Jun 29, 2015 | K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test W.H.P.M., Inc. | DJR |
| May 31, 2013 | K131232 | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) Guangzhou Wondfo Biotech Co., Ltd. | DJR |
| Nov 18, 2010 | K092272 | RANDOX METHADONE ASSAY Randox Laboratories, Ltd., GB | DJR |
| Nov 9, 2010 | K092258 | RANDOX METABOLITE (EDDP) ASSAY Randox Laboratories, Ltd., GB | DJR |
| Apr 19, 2010 | K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP Biosite Incorporated | DJR |
| Jan 14, 2009 | K081378 | DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS Thermo Fisher Scientific | DJR |
| Nov 22, 2006 | K062637 | VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V Ortho-Clinical Diagnostics, Inc. | DJR |
| Jun 22, 2006 | K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 Biosite Incorporated | DJR |
| Jun 9, 2006 | K052197 | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST W.H.P.M., Inc. | DJR |
| Mar 29, 2006 | K051058 | METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DJR |
| May 10, 2004 | K040570 | RANDOX METHADONE ASSAY Randox Laboratories, Ltd., GB | DJR |
| Oct 10, 2003 | K031797 | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) Lin-Zhi International, Inc. | DJR |
| Aug 27, 2003 | K023617 | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY Microgenics Corp. | DJR |
| Aug 25, 2003 | K023856 | VISUALINE METHADONE DIPSTRIPTEST Sun Biomedical Laboratories, Inc. | DJR |
| Apr 30, 2003 | K023869 | 'RAPIDTEC'-5M-MULTIPLE DIP TEST American Bio Medica Corp. | DJR |
| Dec 12, 2002 | K023317 | METHADONE ENZYME IMMUNOASSAY Lin-Zhi International, Inc. | DJR |
| Nov 22, 2002 | K023252 | RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 Icn Biomedicals, Inc. | DJR |
| Jul 16, 2002 | K021512 | COBAS INTEGRA ONLINE DAT II METHADONE II Roche Diagnostics Corp. | DJR |
| Jul 16, 2002 | K021505 | ONLINE DAT II METHADONE II Roche Diagnostics Corp. | DJR |
| Mar 20, 2002 | K013001 | METHADONE Abbott Laboratories | DJR |
| Nov 26, 2001 | K013796 | LIVESURE METHADONE SCREEN TESTS Pan Probe Biotech, Inc. | DJR |
| Nov 20, 2001 | K012164 | 'RAPIDONE'-METHADONE TEST American Bio Medica Corp. | DJR |
| Oct 15, 2001 | K012595 | ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE ACON Laboratories, Inc. | DJR |
| Jul 31, 2001 | K011131 | METHADONE MICROPLATE EIA URINE APPLICATION Cozart Bioscience , Ltd., GB | DJR |
| May 29, 2001 | K010015 | INSTANT-VIEW METHADONE URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DJR |
| May 29, 2001 | K010014 | INSTANT-VIEW METHADONE URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DJR |
| Apr 26, 2001 | K010962 | EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 Syva Co., Dade Behring, Inc. | DJR |
| Nov 29, 2000 | K002010 | STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 OraSure Technologies, Inc. | DJR |
| Nov 22, 2000 | K002417 | BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D Branan Medical Corporation | DJR |
| Apr 5, 2000 | K000466 | URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A Dade Behring, Inc. | DJR |
| Jan 20, 2000 | K994005 | SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL Syva Co. | DJR |
| Apr 15, 1999 | K991080 | ACCUSIGN MTD, BIOSIGN MTD Princeton BioMeditech Corp. | DJR |
| Feb 5, 1999 | K982938 | QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 Phamatech | DJR |
| Dec 11, 1998 | K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE Roche Diagnostic Systems, Inc. | DJR |
| Sep 4, 1998 | K981314 | VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE Sun Biomedical Laboratories, Inc. | DJR |
| May 26, 1998 | K980746 | CEDIA DAU EDDP ASSAY Boehringer Mannheim Corp. | DJR |
| Sep 22, 1997 | K973069 | SYNCHRON SYSTEMS METHADONE REAGENT Beckman Instruments, Inc. | DJR |
| Aug 4, 1997 | K972526 | METHADONE EIA ASSAY Diagnostic Reagents, Inc. | DJR |
| Aug 15, 1996 | K962673 | ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY Princeton BioMeditech Corp. | DJR |
| Nov 17, 1995 | K954227 | CEDIA DAU METHADONE ASSAY Microgenics Corp. | DJR |
| Nov 13, 1995 | K953499 | AXSYM METHADONE Abbott Laboratories | DJR |
| Dec 29, 1994 | K944056 | AUTO-LYTE METHADONE DIA Solarcare Technologies Corp,Inc. | DJR |
| Dec 2, 1994 | K944074 | CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST Beckman Instruments, Inc. | DJR |
| Jan 26, 1994 | K934667 | METHADONE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | DJR |
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