| Labcorp Fentanyl Urine Visual Test (K252684) | Medtox Diagnostics, Inc. | 2026-01-29 |
| Evidence MultiSTAT DOA Urine MultiPlex (K250741) | Randox Laboratories Limited | 2026-01-23 |
| LZI Buprenorphine II Enzyme Immunoassay (K253082) | Lin-Zhi International, Inc. | 2026-01-16 |
| SEFRIA™ Hydrocodone Oral Fluid (K252520) | Immunalysis Corporation | 2025-09-11 |
| Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (K251972) | Healgen Scientific,, LLC | 2025-08-15 |
| LZI Fentanyl III Enzyme Immunoassay (K251634) | Lin-Zhi International, Inc. | 2025-06-18 |
| BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (K240124) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-06-14 |
| Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (K240698) | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-05-10 |
| Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (K231904) | Co-Innovation Biotech Co., Ltd. | 2024-03-08 |
| Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card (K232228) | Shanghai Accurature Diagnostics Co., Ltd. | 2024-02-23 |
| LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) (K232597) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-09 |
| 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 (K232736) | Chemtron Biotech, Inc. | 2023-12-20 |
| Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup (K232659) | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-12-13 |
| ARK Hydrocodone Assay (K231752) | Ark Diagnostics, Inc. | 2023-11-09 |
| Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (K220451) | Randox Laboratories Limited | 2023-10-05 |
| Evidence MultiSTAT DOA Urine MultiPlex (K221550) | Randox Laboratories Limited | 2023-10-05 |
| CEDIA Heroin Metabolite (6-AM) Assay (K231007) | Microgenics Corporation | 2023-09-27 |
| AllTest Fentanyl Rapid Test (Urine) (K231698) | Hangzhou AllTest Biotech Co., Ltd. | 2023-07-31 |
| Emit® II Plus Buprenorphine Assay (K221605) | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 |
| BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx (K230238) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2023-03-31 |
| Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (K222955) | Xenta Biomedical Science Co., Ltd. | 2023-02-06 |
| Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 (K220046) | Shenzhen Superbio Technology Co., Ltd. | 2022-12-13 |
| Immunalysis Tapentadol Urine HEIA (K203527) | Lmmunalysis Corporation | 2022-05-09 |
| SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (K203564) | Immunalysis Corporation | 2021-12-22 |
| AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (K201630) | Assure Tech. (Hangzhou) Co, Ltd. | 2021-08-12 |
| Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair (K201326) | Psychemedics Corporation | 2021-07-27 |
| ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card (K201494) | Advin Biotech, Inc. | 2020-09-17 |
| LZI Oxycodone III Enzyme Immunoassay (K202007) | Lin-Zhi International, Inc. | 2020-09-17 |
| LZI Fentanyl II Enzyme Immunoassay (K201938) | Lin-Zhi International, Inc. | 2020-08-07 |
| LZI Tramadol Enzyme Immunoassay (K201223) | Lin-Zhi International, Inc. | 2020-06-04 |
| ARK Fentanyl II Assay (K200197) | Ark Diagnostics, Inc. | 2020-02-26 |
| CEDIA Heroin Metabolite (6-AM) assay (K192943) | Microgenics Corporation | 2019-12-16 |
| Psychemedics Microplate EIA for Fentanyl in Hair (K182103) | Psychemedics Corporation | 2019-04-18 |
| ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card (K182123) | Advin Biotech, Inc. | 2019-03-29 |
| ARK Tramadol Assay (K182280) | Ark Diagnostics, Inc. | 2018-12-10 |
| LZI Fentanyl Enzyme Immunoassay (K181159) | Lin-Zhi International, Inc. | 2018-12-03 |
| ARK Fentanyl Assay (K180427) | Ark Diagnostics, Inc. | 2018-06-06 |
| Synermed Opiate Enzyme Immunoassay (K172416) | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-04-19 |
| DRI Hydrocodone Assay (K173195) | Microgenics Corporation | 2018-02-13 |
| CEDIA Heroin Metabolite (6-AM) Assay (K173183) | Microgenics Corporation | 2017-11-22 |
| Emit II Plus Oxycodone Assay (K172910) | Siemens Healthcare Diagnostics, Inc. | 2017-10-18 |
| Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators (K161216) | Immunalysis Corporation | 2017-06-14 |
| CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set (K163101) | Microgenics Corporation | 2017-04-06 |
| Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (K153050) | Co-Innovation Biotech Co., Ltd. | 2016-04-26 |
| Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests (K153192) | Chemtron Biotech, Inc. | 2016-04-18 |
| 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. (K152551) | W.H.P.M., Inc. | 2015-11-09 |
| 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 (K150606) | Siemens Healthcare Diagnostics, Inc. | 2015-10-23 |
| DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls (K150502) | Microgenics Corporation | 2015-10-09 |
| Wondfo CR3 Keyless Split Sample Cup (K151478) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-07-01 |
| Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls (K143502) | Immunalysis Corporation | 2015-05-20 |
| Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 (K143599) | Chemtron Biotech, Inc. | 2015-04-17 |
| Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls (K150275) | Immunalysis Corporation | 2015-03-09 |
| CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids (K150179) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-02-25 |
| LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 (K141205) | Lin-Zhi International, Inc. | 2015-02-13 |
| IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY (K141803) | Immunalysis Corporation | 2015-02-12 |
| Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) (K143187) | Healgen Scientific,, LLC | 2015-01-27 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE (K140671) | Omega Laboratories, Inc. | 2015-01-08 |
| Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) (K142280) | Healgen Scientific,, LLC | 2014-10-16 |
| Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests (K142396) | Chemtron Biotech, Inc. | 2014-10-09 |
| ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD (K140748) | Co-Innovation Biotech Co., Ltd. | 2014-08-20 |
| IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS (K141406) | Immunalysis Corporation | 2014-07-01 |
| LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) (K141055) | Lin-Zhi International, Inc. | 2014-06-13 |
| CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) (K140089) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-04-08 |
| STATUS DS OXY (K130650) | Princeton BioMeditech Corp. | 2014-02-26 |
| RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK (K133642) | Biophor Diagnostics, Inc. | 2014-01-24 |
| IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY (K131168) | Immunalysis Corporation | 2014-01-17 |
| QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST (K130275) | Tianjin New Bay Bioresearch Co., Ltd. | 2013-09-26 |
| FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE (K122064) | Tianjin New Bay Bioresearch Co., Ltd. | 2013-05-07 |
| WONDOFO MULTI-DRUG URINE TEST CUP / PANEL (K130665) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-04-09 |
| ACON BUP ONE STEP BUPRENORPHINE TEST STRIP (K130055) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-02-14 |
| PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR (K123799) | Psychemedics Corp. | 2013-02-08 |
| RANDOX OPIATES ASSAY (K113747) | Randox Laboratories Limited | 2012-08-24 |
| LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS (K120763) | Lin-Zhi International, Inc. | 2012-06-01 |
| LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS (K120761) | Lin-Zhi International, Inc. | 2012-05-08 |
| PSYCHEMEDICS OPIATES EIA (K111926) | Psychemedics Corp. | 2012-05-01 |
| WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST (K113624) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-03-12 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES (K103161) | Omega Laboratories, Inc. | 2011-12-13 |
| WONDFO METHADONE URINE TEST,OPIATE TEST (K112310) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-08 |
| OPIATE ENZYME IMMUNOASSAY (K110298) | Lin-Zhi International, Inc. | 2011-07-15 |
| THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (K101754) | Microgenics Corp. | 2011-04-08 |
| EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C (K102779) | Siemens Healthcare Diagnostics, Inc. | 2011-03-18 |
| ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A (K093867) | Roche Diagnostics | 2011-02-11 |
| MEDTOX BUPRENORPHINE TEST (K100951) | Medtox Diagnostics, Inc. | 2010-10-18 |
| WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES (K093175) | Guangzhou Wondfo Biotech Co., Ltd. | 2010-08-25 |
| 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS (K101195) | Lin-Zhi International, Inc. | 2010-07-06 |
| INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) (K100051) | Alfa Scientific Designs, Inc. | 2010-07-06 |
| PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM (K100023) | Medtox Diagnostics, Inc. | 2010-04-05 |
| UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; (K091612) | Ucp Biosciences, Inc. | 2010-02-24 |
| BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS (K090844) | Lin-Zhi International, Inc. | 2009-07-30 |
| PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM (K091454) | Medtox Diagnostics, Inc. | 2009-07-24 |
| BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS (K081008) | Lin-Zhi International, Inc. | 2008-12-22 |
| FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD (K082508) | Branan Medical Corporation | 2008-11-21 |
| IMDX SYSTEMS (K063699) | Novx Systems, Inc. | 2007-06-01 |
| MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE (K063545) | Alfa Scientific Designs, Inc. | 2007-05-07 |
| AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 (K063015) | Ameditech, Inc. | 2006-12-20 |
| VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III (K062460) | Ortho-Clinical Diagnostics, Inc. | 2006-12-15 |
| RAPIDONE-BUPRENORPHINE TEST (K060760) | American Bio Medica Corp. | 2006-08-07 |
| INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST (K060527) | Alfa Scientific Designs, Inc. | 2006-07-25 |
| MP RAPIDOXY TEST STRIP, MODEL 07RD-7073 (K051958) | Mp Biomedicals, LLC | 2006-07-21 |
| ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 (K053037) | Acro Biotech, LLC | 2006-06-15 |