| 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 |
| TOXCUP DRUG SCREEN CUP (K122633) | Branan Medical Corp. | 2013-02-07 |
| FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD (K122752) | Branan Medical Corp. | 2013-01-30 |
| UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS (K123863) | Ucp Biosciences, Inc. | 2013-01-09 |
| NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR (K123683) | Aerocrine AB | 2012-12-27 |
| WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) (K122961) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-12-21 |
| ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS (K120936) | Microgenics Corporation | 2012-12-13 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) (K122759) | Omega Laboratories, Inc. | 2012-12-05 |
| UCP HOME DRUG SCREENING TEST CUPS (K122419) | Ucp Biosciences, Inc. | 2012-11-30 |
| CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS (K123080) | Chemtron Biotech, Inc. | 2012-11-29 |
| 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 |
| VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (K120466) | Nanosphere, Inc. | 2012-11-06 |
| ALCO-SCREEN 02 (K121256) | Chematics, Inc. | 2012-09-12 |
| RANDOX OPIATES ASSAY (K113747) | Randox Laboratories Limited | 2012-08-24 |
| WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST (K121987) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-08-01 |
| WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST (K121557) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-07-25 |
| DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (K121122) | Biochemical Diagnostic, Inc. | 2012-07-03 |
| LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS (K120763) | Lin-Zhi International, Inc. | 2012-06-01 |
| LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (K121143) | Bio-Rad Laboratories | 2012-05-18 |
| TISSUE OF ORIGIN TEST KIT FFPE (K120489) | Pathwork Diagnostics, Inc. | 2012-05-17 |
| CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS (K121339) | Chemtron Biotech, Inc. | 2012-05-17 |
| RANDOX COCAINE METABOLITE (K113751) | Randox Laboratories, Ltd. | 2012-05-08 |
| LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS (K120761) | Lin-Zhi International, Inc. | 2012-05-08 |
| WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL (K121166) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-05-08 |
| PSYCHEMEDICS METHAMPHETAMINE EIA (K111927) | Psychemedics Corp. | 2012-05-01 |
| PSYCHEMEDICS COCAINE EIA (K111925) | Psychemedics Corp. | 2012-05-01 |
| PSYCHEMEDICS CANNABINOIDS EIA (K111929) | Psychemedics Corp. | 2012-05-01 |
| PSYCHEMEDICS OPIATES EIA (K111926) | Psychemedics Corp. | 2012-05-01 |
| WUNDER TEST (K102428) | Hien Helen Nguyen | 2012-04-18 |
| ORATECT ORAL FLUID DRUG SCREEN DEVICES (K103227) | Branan Medical Corporation | 2012-04-11 |
| LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK (K120504) | Bio-Rad Laboratories, Inc. | 2012-03-27 |
| WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST (K113624) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-03-12 |
| QUICKSCREEN COCAINE 150 SCREENING TEST (K103295) | Phamatech, Inc. | 2012-02-01 |
| LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS (K113661) | Lin-Zhi International, Inc. | 2012-01-23 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (K112808) | Omega Laboratories, Inc. | 2012-01-23 |
| ROCHE ACETAMINOPHEN ASSAY (K110726) | Roche Diagnostics | 2011-12-23 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES (K103161) | Omega Laboratories, Inc. | 2011-12-13 |
| PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL (K111363) | Medica Corp. | 2011-12-06 |
| AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) (K113501) | Ameditech, Inc. | 2011-12-05 |
| LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS (K113139) | Lin-Zhi International, Inc. | 2011-11-22 |
| PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM (K110614) | Seju Engineering Co., Ltd. | 2011-11-21 |
| ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL (K111005) | Medica Corp. | 2011-11-15 |
| AMEDITECH IMMUTEST MILTI-DRUG SCREEN (K113046) | Ameditech, Inc. | 2011-11-10 |
| DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE (K112142) | Siemens Healthcare Diagnostics | 2011-11-04 |
| ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS (K103627) | Abbott Laboratories | 2011-10-14 |
| RANDOX DIGOXIN ASSAY (K102346) | Randox Laboratories, Ltd. | 2011-10-14 |
| DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) (K102772) | Siemens Heatlhcare Diagnostics, Inc. | 2011-10-07 |
| TECO DIAGNOSTICS SALIVA ALCOHOL TEST (K111206) | Teco Diagnostics | 2011-10-04 |
| WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P (K112071) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-23 |
| WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST (K112236) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-19 |
| CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD (K111322) | Chemtron Biotech, Inc. | 2011-09-14 |
| WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST (K112395) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-09 |
| WONDFO METHADONE URINE TEST,OPIATE TEST (K112310) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-08 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) (K101973) | Omega Laboratories, Inc. | 2011-08-16 |
| WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST (K111560) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-07-15 |
| OPIATE ENZYME IMMUNOASSAY (K110298) | Lin-Zhi International, Inc. | 2011-07-15 |
| LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL (K110239) | Lin-Zhi International, Inc. | 2011-06-23 |
| RANDOX BARITURATES ASSAY (K092268) | Randox Laboratories, Ltd. | 2011-05-25 |
| CANNABINOIDS URINE TEST (K110182) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-05-20 |
| RANDOX METHAMPHETAMINE ASSAY (K092266) | Randox Laboratories, Ltd. | 2011-05-09 |
| 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 |
| UCP DRUG SCREENING TEST CUPS (K110515) | Ucp Biosciences, Inc. | 2011-04-20 |
| CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET (K092269) | Randox Laboratories, Ltd. | 2011-04-08 |
| THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (K101754) | Microgenics Corp. | 2011-04-08 |
| THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY (K101742) | Microgenics Corp. | 2011-04-08 |
| THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (K101752) | Microgenics Corp. | 2011-04-08 |
| THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY (K101753) | Microgenics Corp. | 2011-04-08 |
| THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY (K101744) | Microgenics Corp. | 2011-04-08 |
| THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY (K101745) | Microgenics Corp. | 2011-04-08 |
| ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST (K102225) | Alcopro, Inc. | 2011-04-06 |
| ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (K102699) | Abbott Laboratories | 2011-04-01 |
| THERMO SCIENTIFIC MAS R DOA TOTAL (K103656) | Microgenics Corporation | 2011-03-24 |
| 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 |
| RANDOX ECSTASY (MDMA) ASSAY (K092275) | Randox Laboratories, Ltd. | 2011-03-01 |
| ROCHE FLUDI METHAMPHETAMINE (K093884) | Roche Diagnostics | 2011-02-25 |
| ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A (K093867) | Roche Diagnostics | 2011-02-11 |
| THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS (K100144) | Microgenics Corp. | 2011-02-11 |
| ROCHE ORAL FLUID COCAINE (K101160) | Roche Diagnostics | 2011-02-11 |
| SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 (K103373) | Beckman Coulter, Inc. | 2011-02-07 |
| CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS (K102203) | Chemtron Biotech, Inc. | 2011-01-20 |
| BREATHSCN PRO (K102338) | Akers Biosciences, Inc. | 2011-01-12 |
| LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS (K102210) | Lin-Zhi International, Inc. | 2010-12-28 |
| ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 (K101574) | Ark Diagnostics, Inc. | 2010-11-23 |
| RANDOX METHADONE ASSAY (K092272) | Randox Laboratories, Ltd. | 2010-11-18 |
| RANDOX METABOLITE (EDDP) ASSAY (K092258) | Randox Laboratories, Ltd. | 2010-11-09 |
| RANDOX ETHANOL ASSAY (K092273) | Randox Laboratories, Ltd. | 2010-11-01 |
| ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL (K101305) | Ark Diagnostics, Inc. | 2010-10-29 |
| INFINITI CYP2C19 ASSAY (K101683) | Autogenomics, Incorporated | 2010-10-25 |
| MEDTOX BUPRENORPHINE TEST (K100951) | Medtox Diagnostics, Inc. | 2010-10-18 |
| RANDOX BENZODIAZEPINE ASSAY (K092274) | Randox Laboratories, Ltd. | 2010-10-15 |
| NIOX MINO MODEL 09-1000 (K101034) | Aerocrine AB | 2010-09-02 |
| XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) (K093420) | Luminex Molecular Diagnostics, Inc. | 2010-08-26 |
| 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 |
| MISSION SALIVA ALCOHOL TEST STRIP (K093879) | ACON Laboratories, Inc. | 2010-08-06 |
| CONTRALCO (K100879) | Contralco | 2010-08-04 |
| ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 (K100200) | Siemens Healthcare Diagnostics | 2010-08-02 |
| AMPHETAMINES II ASSAY (K093664) | Roche Diagnostics Corp. | 2010-07-28 |
| 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 |