| K192433 | LZI Methadone II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2019-10-04 |
| K182779 | ARK EDDP Assay | Ark Diagnostics, Inc. | 2018-11-21 |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | Lin-Zhi International, Inc. | 2017-06-26 |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) | W.H.P.M., Inc. | 2016-08-17 |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | Assure Tech. Co., Ltd. | 2015-10-05 |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets | Immunalysis Corporation | 2015-07-24 |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | W.H.P.M., Inc. | 2015-06-29 |
| K131232 | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-05-31 |
| K092272 | RANDOX METHADONE ASSAY | Randox Laboratories, Ltd. | 2010-11-18 |
| K092258 | RANDOX METABOLITE (EDDP) ASSAY | Randox Laboratories, Ltd. | 2010-11-09 |
| K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP | Biosite Incorporated | 2010-04-19 |
| K081378 | DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS | Thermo Fisher Scientific | 2009-01-14 |
| K062637 | VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 |
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 | Biosite Incorporated | 2006-06-22 |
| K052197 | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST | W.H.P.M., Inc. | 2006-06-09 |