| DRI Ecstasy Plus Assay (K240670) | Microgenics Corporation | 2024-10-30 |
| AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx (K233019) | Hangzhou AllTest Biotech Co., Ltd. | 2023-12-13 |
| Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (K231137) | Xenta Biomedical Science Co., Ltd. | 2023-05-19 |
| Quidel Triage® TOX Drug Screen, 94600 (K200363) | Quidel Cardiovascular, Inc. | 2020-03-11 |
| Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (K191099) | Atlas Medical | 2019-10-03 |
| Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (K182719) | Quidel Cardiovascular, Inc. | 2019-06-19 |
| Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) (K182738) | Hangzhou AllTest Biotech Co., Ltd. | 2019-03-27 |
| BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use (K180879) | Shanghai Venture Bio-Tech Co., Ltd. | 2018-12-14 |
| QuickScreen Pro Multi Drug Screening Test, Model 9395Z (K181945) | Phamatech, Inc. | 2018-10-18 |
| INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (K173303) | Alfa Scientific Designs, Inc. | 2018-02-23 |
| CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests (K161251) | Hangzhou Clongene Biotech Co., Ltd. | 2016-08-30 |
| Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) (K152122) | Alfa Scientific Designs, Inc. | 2016-06-24 |
| UCP COMPACT DRUG TESTS (K152908) | Ucp Biosciences, Inc. | 2016-05-03 |
| ACCU NEWS Drug Screening Test Card/Urine Cup (K152590) | Coretests, Inc. | 2016-04-15 |
| AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) (K153465) | Assure Tech. (Hangzhou) Co, Ltd. | 2016-03-31 |
| Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) (K152269) | Healgen Scientific,, LLC | 2015-09-09 |
| UCP Drug Test Mini Cups (K151213) | Ucp Biosciences, Inc. | 2015-08-21 |
| Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) (K142855) | Omega Laboratories, Inc. | 2015-07-28 |
| RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET (K141748) | Biophor Diagnostics, Inc. | 2015-05-20 |
| Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set (K143500) | Immunalysis Corporation | 2015-02-06 |
| Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (K142800) | Co-Innovation Biotech Co., Ltd. | 2014-12-11 |
| Chemtrue Multi-Panel DOA DIP Card Tests (K142580) | Chemtron Biotech, Inc. | 2014-12-01 |
| CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE (K141532) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-07-14 |
| QUICKSCREEN AMPHETINE 500 TEST (K131069) | Phamatech, Inc. | 2014-05-14 |
| UCP MULTI-DRUG TEST KEY CUPS (K132812) | Ucp Biosciences, Inc. | 2014-03-06 |
| WONDFO MULTI-DRUG URINE TEST CUP, PANEL (K133968) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-02-25 |
| LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (K131653) | Lin-Zhi International, Inc. | 2014-02-04 |
| ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD (K131110) | Co-Innovation Biotech Co., Ltd. | 2014-01-15 |
| GENPRIME DRUGS OF ABUSE READER SYSTEM (K130082) | Genprime, Inc. | 2013-12-20 |
| INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) (K131645) | Alfa Scientific Designs, Inc. | 2013-10-07 |
| UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS (K131811) | Ucp Biosciences, Inc. | 2013-07-19 |
| Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (K122809) | Advin Biotech | 2013-06-17 |
| POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE (K121065) | Polymed Therapeutics, Inc. | 2013-05-24 |
| UCP HOME DRUG SCREENING TEST; CARDS, CUPS (K130463) | Ucp Biosciences, Inc. | 2013-05-15 |
| PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE (K130811) | Psychemedics Corp. | 2013-05-02 |
| UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS (K123863) | Ucp Biosciences, Inc. | 2013-01-09 |
| WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) (K122961) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-12-21 |
| UCP HOME DRUG SCREENING TEST CUPS (K122419) | Ucp Biosciences, Inc. | 2012-11-30 |
| WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; (K122904) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-11-15 |
| WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST (K121987) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-08-01 |
| CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS (K121339) | Chemtron Biotech, Inc. | 2012-05-17 |
| AMEDITECH IMMUTEST MILTI-DRUG SCREEN (K113046) | Ameditech, Inc. | 2011-11-10 |
| WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST (K111560) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-07-15 |
| ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID (K110446) | Roche Diagnostics | 2011-05-03 |
| THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY (K101745) | Microgenics Corp. | 2011-04-08 |
| RANDOX ECSTASY (MDMA) ASSAY (K092275) | Randox Laboratories, Ltd. | 2011-03-01 |
| CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS (K102203) | Chemtron Biotech, Inc. | 2011-01-20 |
| LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS (K102210) | Lin-Zhi International, Inc. | 2010-12-28 |
| AMPHETAMINES II ASSAY (K093664) | Roche Diagnostics Corp. | 2010-07-28 |
| THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY (K093114) | Microgenics Corp. | 2010-05-12 |
| AMPHETAMINES II (K083764) | Roche Diagnostics Corp. | 2010-02-03 |
| UCP HOME DRUG SCREENING TESTS (K091588) | Ucp Biosciences, Inc. | 2009-09-04 |
| MEDTOXSCAN (K080635) | Medtox Diagnostics, Inc. | 2009-02-13 |
| IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL (K080057) | Novx Systems, Inc. | 2008-10-31 |
| HOMECHECK MULTIPLE DRUG CUP TEST (K071489) | Tianjin New Bay Bioresearch Co., Ltd. | 2008-03-28 |
| AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 (K063379) | Amedica Biotech, Inc. | 2006-12-11 |
| FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST (K061617) | Tianjin New Bay Bioresearch Co., Ltd. | 2006-11-22 |
| VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS (K062077) | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 |
| INNOVACON SPECTRUM II TEST CARD (K061718) | Innovacon, Inc. | 2006-11-13 |
| LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS (K063024) | Lin-Zhi International, Inc. | 2006-10-30 |
| ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS (K061005) | Applied Dna Technologies, Inc. | 2006-10-04 |
| ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC (K060810) | Ind Diagnostic, Inc. | 2006-08-07 |
| RAPIDTOX (K053359) | American Bio Medica Corp. | 2006-05-25 |
| DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 (K053337) | Dade Behring, Inc. | 2006-05-19 |
| FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE (K052882) | Tianjin New Bay Bioresearch Co., Ltd. | 2006-02-15 |
| ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 (K053032) | Acro Biotech, LLC | 2006-02-09 |
| FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY (K052115) | First Check Diagnostics, LLC | 2005-12-29 |
| AMEDITECH DRUGSMARTCUP (K053175) | Ameditech, Inc. | 2005-12-08 |
| QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) (K051161) | Quest Diagnostics, Inc. | 2005-11-22 |
| SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS (K050394) | Medtox Diagnostics, Inc. | 2005-10-25 |
| IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS (K051579) | Immunalysis Corporation | 2005-10-21 |
| FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY (K051966) | Worldwide Medical, LLC | 2005-09-07 |
| RAPID READER (K041696) | American Bio Medica Corp. | 2005-07-12 |
| ON TRAK TESTCARD (K051235) | Varian, Inc. | 2005-06-08 |
| UCP RAPID DRUG SCREENING TESTS (K050540) | Ucp Biosciences, Inc. | 2005-04-29 |
| AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III (K050186) | Ameditech, Inc. | 2005-03-04 |
| EMIT II PLUS ECSTASY ASSAY (K043028) | Dade Behring, Inc. | 2005-01-07 |
| ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE (K041822) | ACON Laboratories, Inc. | 2004-09-16 |
| ACON TRI-FECT DRUG SCREEN TEST DEVICE (K041743) | ACON Laboratories, Inc. | 2004-09-09 |
| ACON MULTI-CLIN DRUG SCREEN TEST DEVICE (K041685) | ACON Laboratories, Inc. | 2004-08-30 |
| COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT (K033743) | Cozart Bioscience , Ltd. | 2004-06-03 |
| FIRST SIGN DRUG OF ABUSE SCREENING TEST (K032575) | W.H.P.M., Inc. | 2004-05-19 |
| MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 (K033566) | Rapid Diagnostics, Inc. | 2004-05-17 |
| RANDOX AMPHETAMINE CLASS ASSAY (K040350) | Randox Laboratories, Ltd. | 2004-05-12 |
| URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE (K040133) | Dade Behring, Inc. | 2004-04-08 |
| MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 (K040203) | Branan Medical Corp. | 2004-03-25 |
| AMEDITECH IMMU TEST DRUG SCREEN PANEL (K040092) | Ameditech, Inc. | 2004-03-08 |
| ONTRAK TESTCUP II AND ONSITE CUPKIT (K033902) | Varian, Inc. | 2004-01-20 |
| VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK (K033659) | Varian, Inc. | 2004-01-06 |
| ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) (K033094) | Lin-Zhi International, Inc. | 2003-12-19 |
| ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD (K031759) | ACON Laboratories, Inc. | 2003-08-04 |
| SYVA EMIT II PLUS AMPHETAMINES ASSAY (K031004) | Dade Behring, Inc. | 2003-06-06 |
| ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST (K023712) | Advantage Diagnostics Corp. | 2003-01-31 |
| AMEDICA DRUG SCREEN AMPHETAMINE TEST (K023104) | Amedica Biotech, Inc. | 2002-12-16 |
| INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST (K022564) | Alfa Scientific Designs, Inc. | 2002-08-30 |
| 'RAPIDTEC' 5A MULTIPLE DIP TEST (K021114) | American Bio Medica Corp. | 2002-07-23 |
| FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) (K020869) | Worldwide Medical Corp. | 2002-06-11 |
| STARTOX DRUG OF ABUSE SCREENING TEST (K021006) | Starplex Scientific, Inc. | 2002-06-10 |
| AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) (K020395) | Lin-Zhi International, Inc. | 2002-06-04 |
| TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 (K014247) | Biosite Incorporated | 2002-06-03 |