| Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K151771) | Immunalysis Corporation | 2016-01-05 |
| Wondfo Propoxyphene Urine Test (K152495) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-11-23 |
| 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 |
| EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana (K152643) | Nantong Egens Biotech Co., Ltd. | 2015-11-02 |
| 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 |
| Carbamazepine Gen 4 (K151578) | Roche Diagnostics Operations (Rdo) | 2015-10-22 |
| DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls (K150502) | Microgenics Corporation | 2015-10-09 |
| AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K152025) | Assure Tech. Co., Ltd. | 2015-10-05 |
| Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls (K142293) | Biophor Diagnostics, Inc. | 2015-09-18 |
| 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 |
| Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) (K151348) | Healgen Scientific,, LLC | 2015-08-18 |
| Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K151642) | Healgen Scientific,, LLC | 2015-08-13 |
| 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 COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET (K142129) | Biophor Diagnostics, Inc. | 2015-07-24 |
| Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets (K151395) | Immunalysis Corporation | 2015-07-24 |
| EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine (K151557) | Nantong Egens Biotech Co., Ltd. | 2015-07-16 |
| LeadCare Plus Blood Lead Testing System (K142705) | Magellan Diagnostics | 2015-07-07 |
| Wondfo CR3 Keyless Split Sample Cup (K151478) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-07-01 |
| Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set (K150925) | Immunalysis Corporation | 2015-06-29 |
| First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (K151441) | W.H.P.M., Inc. | 2015-06-29 |
| Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set (K151203) | Immunalysis Corporation | 2015-06-05 |
| AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup (K151211) | Assure Tech. Co., Ltd. | 2015-06-04 |
| LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls (K141320) | Lin-Zhi International, Inc. | 2015-05-28 |
| 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 Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls (K143502) | Immunalysis Corporation | 2015-05-20 |
| Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K150356) | Healgen Scientific,, LLC | 2015-05-13 |
| Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) (K150791) | Healgen Scientific,, LLC | 2015-04-24 |
| Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 (K143599) | Chemtron Biotech, Inc. | 2015-04-17 |
| CR3 Keyless Split Sample Cup Morphine - Methamphetamine (K150602) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-04-07 |
| Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls (K150275) | Immunalysis Corporation | 2015-03-09 |
| Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) (K150096) | Healgen Scientific,, LLC | 2015-03-04 |
| First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (K150162) | W.H.P.M., Inc. | 2015-02-26 |
| NIOX VERO Airway Inflammation Monitor (K150233) | Aerocrine AB | 2015-02-26 |
| 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 |
| Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set (K143500) | Immunalysis Corporation | 2015-02-06 |
| Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) (K143187) | Healgen Scientific,, LLC | 2015-01-27 |
| CR3 Keyless Split Sample Cup Secobarbital- Methadone (K143535) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-01-13 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE (K140671) | Omega Laboratories, Inc. | 2015-01-08 |
| CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (K142609) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-12-18 |
| RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU (K133047) | Biophor Diagnostics, Inc. | 2014-12-18 |
| Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (K142800) | Co-Innovation Biotech Co., Ltd. | 2014-12-11 |
| GenPrime Snap-Top Split Key Cup (K140665) | Genprime, Inc. | 2014-12-08 |
| Chemtrue Multi-Panel DOA DIP Card Tests (K142580) | Chemtron Biotech, Inc. | 2014-12-01 |
| COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR (K141928) | Roche Diagnostics Operations (Rdo) | 2014-11-25 |
| NIOX VERO AIRWAY INFLAMMATION MONITOR (K133898) | Aerocrine AB | 2014-11-06 |
| 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 |
| First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test (K142353) | W.H.P.M., Inc. | 2014-10-07 |
| FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K142408) | Polymed Therapeutics, Inc. | 2014-09-25 |
| ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD (K140748) | Co-Innovation Biotech Co., Ltd. | 2014-08-20 |
| HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) (K141647) | Healgen Scientific,, LLC | 2014-07-17 |
| CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE (K141532) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-07-14 |
| IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS (K141406) | Immunalysis Corporation | 2014-07-01 |
| ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD (K140215) | Co-Innovation Biotech Co., Ltd. | 2014-06-16 |
| LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) (K141055) | Lin-Zhi International, Inc. | 2014-06-13 |
| HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST (K140546) | Healgen Scientific,, LLC | 2014-06-06 |
| QUICKSCREEN AMPHETINE 500 TEST (K131069) | Phamatech, Inc. | 2014-05-14 |
| CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) (K140089) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-04-08 |
| LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (K131652) | Lin-Zhi International, Inc. | 2014-03-21 |
| UCP MULTI-DRUG TEST KEY CUPS (K132812) | Ucp Biosciences, Inc. | 2014-03-06 |
| STATUS DS OXY (K130650) | Princeton BioMeditech Corp. | 2014-02-26 |
| WONDFO MULTI-DRUG URINE TEST CUP, PANEL (K133968) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-02-25 |
| LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS (K133710) | Lin-Zhi International, Inc. | 2014-02-21 |
| LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (K131653) | Lin-Zhi International, Inc. | 2014-02-04 |
| 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 |
| 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 |
| SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ (K132688) | Biochemical Diagnostics, Inc. | 2013-12-16 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (K131128) | Omega Laboratories, Inc. | 2013-11-13 |
| QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE (K130213) | Lumiquick Diagnostics, Inc. | 2013-10-18 |
| RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR (K132096) | Biophor Diagnostics, Inc. | 2013-10-18 |
| INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) (K131645) | Alfa Scientific Designs, Inc. | 2013-10-07 |
| WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) (K132630) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-09-27 |
| QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST (K130275) | Tianjin New Bay Bioresearch Co., Ltd. | 2013-09-26 |
| MULTICHEM WBT (K132174) | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
| XTAG CYP2C19 KIT V3 (K131565) | Luminex Molecular Diagnostics, Inc. | 2013-09-11 |
| ARCHITECT IVANCOMYCIN (K123947) | Biokit, S.A. | 2013-08-29 |
| THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY (K122766) | Microgenics Corp. | 2013-08-20 |
| LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM (K123563) | Magellan Diagnostics | 2013-08-20 |
| SPARTAN RX CYP2C19 TEST SYSTEM (K123891) | Spartan Bioscience, Inc. | 2013-08-12 |
| QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS (DEN130005) | Centers for Disease Control and Prevention | 2013-08-08 |
| BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 (K132090) | Randox Laboratories, Ltd. | 2013-08-08 |
| WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) (K131754) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-07-31 |
| 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 |
| ABBOTT CARBAMAZEPINE ASSAY (K123518) | Microgenics Corporation | 2013-06-05 |
| WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) (K131232) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-05-31 |
| POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE (K121065) | Polymed Therapeutics, Inc. | 2013-05-24 |
| XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) (K130189) | Luminex Molecular Diagnostics, Inc. | 2013-05-21 |
| UCP HOME DRUG SCREENING TEST; CARDS, CUPS (K130463) | Ucp Biosciences, Inc. | 2013-05-15 |
| FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE (K122064) | Tianjin New Bay Bioresearch Co., Ltd. | 2013-05-07 |
| PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE (K130811) | Psychemedics Corp. | 2013-05-02 |
| PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE (K123470) | Pas Systems International, Inc. | 2013-04-29 |
| ABBOTT PHENOBARBITAL ASSAY (K123271) | Microgenics Corp. | 2013-04-26 |
| WONDOFO MULTI-DRUG URINE TEST CUP / PANEL (K130665) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-04-09 |
| ALCO-SCREEN (K121247) | Chematics, Inc. | 2013-03-22 |