| ARK Lacosamide Assay (K201089) | Ark Diagnostics, Inc. | 2021-08-05 |
| Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair (K201326) | Psychemedics Corporation | 2021-07-27 |
| ADVIA Centaur® Digoxin assay (K193397) | Siemens Healthcare Diagnostics, Inc. | 2021-07-16 |
| Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair (K201228) | Psychemedics Corporation | 2021-06-25 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (K202453) | Safecare Biotech (Hangzhou) Co., Ltd. | 2021-03-24 |
| Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx (K202567) | Guangzhou Wondfo Biotech Co., Ltd. | 2020-09-25 |
| 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 |
| Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers (K201442) | Diatron Group | 2020-07-31 |
| LZI Tramadol Enzyme Immunoassay (K201223) | Lin-Zhi International, Inc. | 2020-06-04 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (K201120) | Safecare Biotech (Hangzhou) Co., Ltd. | 2020-05-27 |
| Psychemedics Microplate EIA for Cotinine in Hair (K192517) | Psychemedics Corporation | 2020-04-22 |
| Pointe Scientific Cocaine Metabolite Enzyme Immunoassay (K191638) | Medtest DX | 2020-03-12 |
| Quidel Triage® TOX Drug Screen, 94600 (K200363) | Quidel Cardiovascular, Inc. | 2020-03-11 |
| ARK Fentanyl II Assay (K200197) | Ark Diagnostics, Inc. | 2020-02-26 |
| BIOEASY Multi-Drug Test Cup (K193480) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2020-01-31 |
| CEDIA Heroin Metabolite (6-AM) assay (K192943) | Microgenics Corporation | 2019-12-16 |
| CEDIA Benzodiazepine Assay (K190968) | Microgenics Corporation | 2019-12-09 |
| LZI Cotinine II Enzyme Immunoassay (K192299) | Lin-Zhi International, Inc. | 2019-11-21 |
| Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (K190397) | Immunalysis Corporation | 2019-11-15 |
| BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 (K192515) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-10-11 |
| LZI Methadone II Enzyme Immunoassay (K192433) | Lin-Zhi International, Inc. | 2019-10-04 |
| Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (K191099) | Atlas Medical | 2019-10-03 |
| BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip (K192301) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-09-20 |
| SAFECARE® THC Urine Strip Test (K191924) | Safecare Biotech (Hangzhou) Co., Ltd. | 2019-08-16 |
| Accurate Multi Panel Drug Urine Test Cup (K191841) | Healstone Biotech, Inc. | 2019-08-07 |
| Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (K182719) | Quidel Cardiovascular, Inc. | 2019-06-19 |
| TruDiagnosis System (K183530) | Akonni Biosystems, Inc. | 2019-05-24 |
| 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 |
| 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 |
| CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (K190412) | Hangzhou Clongene Biotech Co., Ltd. | 2019-03-21 |
| Fenom Pro Nitric Oxide Test (K182874) | Spirosure, Inc. | 2019-02-13 |
| SEKURE Acetaminophen L3K Assay (K180835) | Sekisui Diagnostics P.E.I., Inc. | 2019-02-08 |
| BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx (K180878) | Shanghai Venture Bio-Tech Co., Ltd. | 2018-12-17 |
| 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 |
| ARK Tramadol Assay (K182280) | Ark Diagnostics, Inc. | 2018-12-10 |
| Wondfo T-Cup Multi-Drug Urine Test Cup (K182701) | Guangzhou Wondfo Biotech Co., Ltd. | 2018-12-03 |
| LZI Fentanyl Enzyme Immunoassay (K181159) | Lin-Zhi International, Inc. | 2018-12-03 |
| ARK EDDP Assay (K182779) | Ark Diagnostics, Inc. | 2018-11-21 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (K182654) | Safecare Biotech (Hangzhou) Co., Ltd. | 2018-11-19 |
| QMS Plazomicin Immunoassay (DEN180030) | Microgenics Corporation | 2018-11-19 |
| BIOEASY Multi-Drug Test Cup (K182530) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2018-11-09 |
| Immunalysis Ethyl Alcohol Enzyme Assay (K181553) | Immunalysis Corporation | 2018-10-31 |
| QuickScreen Pro Multi Drug Screening Test, Model 9395Z (K181945) | Phamatech, Inc. | 2018-10-18 |
| OralTox Oral fluid Drug Test (K181305) | Premier Biotech, Inc. | 2018-09-20 |
| AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (K181768) | Assure Tech. (Hangzhou) Co, Ltd. | 2018-08-20 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (K181968) | Safecare Biotech (Hangzhou) Co., Ltd. | 2018-08-20 |
| CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (K181790) | Hangzhou Clongene Biotech Co., Ltd. | 2018-07-26 |
| DRI Cocaine Metabolite Assay (K181499) | Microgenics Corporation | 2018-07-06 |
| ARK Fentanyl Assay (K180427) | Ark Diagnostics, Inc. | 2018-06-06 |
| LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay (DEN170010) | Lin-Zhi International, Inc. | 2018-04-20 |
| Synermed Opiate Enzyme Immunoassay (K172416) | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-04-19 |
| AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (K180349) | Assure Tech. (Hangzhou) Co, Ltd. | 2018-04-05 |
| Tissue of Origin Test Kit-FFPE (K173839) | Cancer Genetics, Inc. | 2018-03-15 |
| CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (K180255) | Hangzhou Clongene Biotech Co., Ltd. | 2018-02-28 |
| 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 |
| DRI Benzodiazepine Assay (K173963) | Microgenics Corporation | 2018-02-21 |
| DRI Hydrocodone Assay (K173195) | Microgenics Corporation | 2018-02-13 |
| First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana (K171695) | W.H.P.M., Inc. | 2018-02-05 |
| OralTox Oral Fluid Drug Test (K171403) | Premier Biotech, Inc. | 2018-02-02 |
| NIOX VERO (K170983) | Circassia AB | 2017-11-22 |
| CEDIA Heroin Metabolite (6-AM) Assay (K173183) | Microgenics Corporation | 2017-11-22 |
| Emit II Plus Cocaine Metabolite Assay (K170293) | Siemens Healthcare Diagnostics, Inc. | 2017-10-25 |
| Emit II Plus Oxycodone Assay (K172910) | Siemens Healthcare Diagnostics, Inc. | 2017-10-18 |
| Psychemedics Microplate EIA for Benzodiazepines in Hair (K163590) | Psychemedics Corporation | 2017-09-15 |
| Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) (K163570) | Carolina Liquid Chemistries Corporation | 2017-08-15 |
| Rapid Tox Cup II (K170222) | American Bio Medica Corp. | 2017-08-15 |
| xTAG CYP2D6 Kit v3 (K170492) | Luminex Molecular Diagnostics, Inc. | 2017-08-11 |
| Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (K163704) | Healgen Scientific,, LLC | 2017-08-02 |
| LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators (K170416) | Lin-Zhi International, Inc. | 2017-06-26 |
| Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators (K161216) | Immunalysis Corporation | 2017-06-14 |
| MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (K162395) | Mp Biomedicals, LLC | 2017-06-02 |
| ARK Voriconazole II Assay Test System (DEN160033) | Ark Diagnostics, Inc. | 2017-05-05 |
| AssureTech Panel Dip Test, AssureTech Quick Cup Test (K170049) | Assure Tech. (Hangzhou) Co, Ltd. | 2017-05-02 |
| CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set (K163101) | Microgenics Corporation | 2017-04-06 |
| Quest Diagnostics HairCheck-DT (Cocaine) (K152232) | Quest Diagnostics Incorporated | 2016-11-18 |
| Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K161714) | Immunalysis Corporation | 2016-10-14 |
| CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests (K161251) | Hangzhou Clongene Biotech Co., Ltd. | 2016-08-30 |
| First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) (K160793) | W.H.P.M., Inc. | 2016-08-17 |
| ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control (K153596) | Ark Diagnostics, Inc. | 2016-08-09 |
| Soberlink Cellular Device and Sober Sky Web Portal (K160613) | Soberlink Healthcare, LLC | 2016-07-14 |
| AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K161044) | Assure Tech. (Hangzhou) Co, Ltd. | 2016-07-06 |
| Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) (K161214) | Guangzhou Wondfo Biotech Co., Ltd. | 2016-06-27 |
| 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 |
| eSensor Warfarin Sensitivity Saliva Test (K152612) | Genmark Diagnostics, Incorporated | 2016-05-26 |
| Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K153597) | Healgen Scientific,, LLC | 2016-05-23 |
| UCP COMPACT DRUG TESTS (K152908) | Ucp Biosciences, Inc. | 2016-05-03 |
| Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (K160202) | Siemens Healthcare Diagnostics, Inc. | 2016-04-27 |
| 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 |
| ACCU NEWS Drug Screening Test Card/Urine Cup (K152590) | Coretests, Inc. | 2016-04-15 |
| Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II (K153301) | Roche Diagnostics | 2016-04-08 |
| 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 |
| CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test (K153741) | Hangzhou Clongene Biotech Co., Ltd. | 2016-03-18 |
| SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana (K153646) | Safecare Biotech (Hangzhou) Co., Ltd. | 2016-03-18 |
| Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K153693) | Immunalysis Corporation | 2016-03-18 |
| Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series (K153474) | Biochemical Diagnostics, Inc. | 2016-02-23 |
| ONLINE TDM Vancomycin Gen.3 (K152245) | Roche Diagnostics Operations (Rdo) | 2016-01-08 |