FDA Product Code
FDA Product Code DJG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3650
510(k) Clearances — 215 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026-01-29 | Traditional | PDF ↗ |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2026-01-23 | Traditional | PDF ↗ |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2026-01-16 | Traditional | PDF ↗ |
| K252520 | SEFRIA Hydrocodone Oral Fluid | Immunalysis Corporation | 2025-09-11 | Traditional | PDF ↗ |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Healgen Scientific,, LLC | 2025-08-15 | Traditional | PDF ↗ |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2025-06-18 | Special | PDF ↗ |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-06-14 | Traditional | PDF ↗ |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-05-10 | Traditional | PDF ↗ |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2024-03-08 | Traditional | PDF ↗ |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card | Shanghai Accurature Diagnostics Co., Ltd. | 2024-02-23 | Traditional | PDF ↗ |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-09 | Traditional | PDF ↗ |
| K232736 | 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 | Chemtron Biotech, Inc. | 2023-12-20 | Traditional | PDF ↗ |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-12-13 | Traditional | PDF ↗ |
| K231752 | ARK Hydrocodone Assay | Ark Diagnostics, Inc. | 2023-11-09 | Traditional | PDF ↗ |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2023-10-05 | Traditional | PDF ↗ |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited | 2023-10-05 | Traditional | PDF ↗ |
| K231007 | CEDIA Heroin Metabolite (6-AM) Assay | Microgenics Corporation | 2023-09-27 | Traditional | PDF ↗ |
| K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023-07-31 | Traditional | PDF ↗ |
| K221605 | Emit® II Plus Buprenorphine Assay | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 | Traditional | PDF ↗ |
| K230238 | BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2023-03-31 | Traditional | PDF ↗ |
| K222955 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. | 2023-02-06 | Traditional | PDF ↗ |
| K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 | Shenzhen Superbio Technology Co., Ltd. | 2022-12-13 | Traditional | PDF ↗ |
| K203527 | Immunalysis Tapentadol Urine HEIA | Lmmunalysis Corporation | 2022-05-09 | Traditional | PDF ↗ |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021-12-22 | Traditional | PDF ↗ |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2021-08-12 | Traditional | PDF ↗ |
| K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair | Psychemedics Corporation | 2021-07-27 | Traditional | PDF ↗ |
| K202007 | LZI Oxycodone III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020-09-17 | Traditional | PDF ↗ |
| K201494 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | Advin Biotech, Inc. | 2020-09-17 | Traditional | PDF ↗ |
| K201938 | LZI Fentanyl II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020-08-07 | Traditional | PDF ↗ |
| K201223 | LZI Tramadol Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020-06-04 | Traditional | PDF ↗ |
| K200197 | ARK Fentanyl II Assay | Ark Diagnostics, Inc. | 2020-02-26 | Traditional | PDF ↗ |
| K192943 | CEDIA Heroin Metabolite (6-AM) assay | Microgenics Corporation | 2019-12-16 | Traditional | PDF ↗ |
| K182103 | Psychemedics Microplate EIA for Fentanyl in Hair | Psychemedics Corporation | 2019-04-18 | Traditional | PDF ↗ |
| K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | Advin Biotech, Inc. | 2019-03-29 | Traditional | PDF ↗ |
| K182280 | ARK Tramadol Assay | Ark Diagnostics, Inc. | 2018-12-10 | Traditional | PDF ↗ |
| K181159 | LZI Fentanyl Enzyme Immunoassay | Lin-Zhi International, Inc. | 2018-12-03 | Traditional | PDF ↗ |
| K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018-06-06 | Traditional | PDF ↗ |
| K172416 | Synermed Opiate Enzyme Immunoassay | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-04-19 | Traditional | PDF ↗ |
| K173195 | DRI Hydrocodone Assay | Microgenics Corporation | 2018-02-13 | Traditional | PDF ↗ |
| K173183 | CEDIA Heroin Metabolite (6-AM) Assay | Microgenics Corporation | 2017-11-22 | Traditional | PDF ↗ |
| K172910 | Emit II Plus Oxycodone Assay | Siemens Healthcare Diagnostics, Inc. | 2017-10-18 | Traditional | PDF ↗ |
| K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators | Immunalysis Corporation | 2017-06-14 | Traditional | PDF ↗ |
| K163101 | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set | Microgenics Corporation | 2017-04-06 | Traditional | PDF ↗ |
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2016-04-26 | Special | PDF ↗ |
| K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests | Chemtron Biotech, Inc. | 2016-04-18 | Traditional | PDF ↗ |
| K152551 | 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. | W.H.P.M., Inc. | 2015-11-09 | Traditional | PDF ↗ |
| K150606 | 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 | Siemens Healthcare Diagnostics, Inc. | 2015-10-23 | Traditional | PDF ↗ |
| K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls | Microgenics Corporation | 2015-10-09 | Traditional | PDF ↗ |
| K151478 | Wondfo CR3 Keyless Split Sample Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2015-07-01 | Special | PDF ↗ |
| K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls | Immunalysis Corporation | 2015-05-20 | Traditional | PDF ↗ |
| K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 | Chemtron Biotech, Inc. | 2015-04-17 | Traditional | PDF ↗ |
| K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls | Immunalysis Corporation | 2015-03-09 | Traditional | PDF ↗ |
| K150179 | CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids | Guangzhou Wondfo Biotech Co., Ltd. | 2015-02-25 | Traditional | PDF ↗ |
| K141205 | LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 | Lin-Zhi International, Inc. | 2015-02-13 | Traditional | PDF ↗ |
| K141803 | IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY | Immunalysis Corporation | 2015-02-12 | Traditional | PDF ↗ |
| K143187 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific,, LLC | 2015-01-27 | Traditional | PDF ↗ |
| K140671 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE | Omega Laboratories, Inc. | 2015-01-08 | Traditional | PDF ↗ |
| K142280 | Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific,, LLC | 2014-10-16 | Traditional | PDF ↗ |
| K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests | Chemtron Biotech, Inc. | 2014-10-09 | Traditional | PDF ↗ |
| K140748 | ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD | Co-Innovation Biotech Co., Ltd. | 2014-08-20 | Traditional | PDF ↗ |
| K141406 | IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS | Immunalysis Corporation | 2014-07-01 | Traditional | PDF ↗ |
| K141055 | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) | Lin-Zhi International, Inc. | 2014-06-13 | Traditional | PDF ↗ |
| K140089 | CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-04-08 | Traditional | PDF ↗ |
| K130650 | STATUS DS OXY | Princeton BioMeditech Corp. | 2014-02-26 | Traditional | PDF ↗ |
| K133642 | RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK | Biophor Diagnostics, Inc. | 2014-01-24 | Traditional | PDF ↗ |
| K131168 | IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY | Immunalysis Corporation | 2014-01-17 | Traditional | PDF ↗ |
| K130275 | QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST | Tianjin New Bay Bioresearch Co., Ltd. | 2013-09-26 | Traditional | PDF ↗ |
| K122064 | FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE | Tianjin New Bay Bioresearch Co., Ltd. | 2013-05-07 | Traditional | PDF ↗ |
| K130665 | WONDOFO MULTI-DRUG URINE TEST CUP / PANEL | Guangzhou Wondfo Biotech Co., Ltd. | 2013-04-09 | Special | PDF ↗ |
| K130055 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP | Guangzhou Wondfo Biotech Co., Ltd. | 2013-02-14 | Traditional | PDF ↗ |
| K123799 | PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR | Psychemedics Corp. | 2013-02-08 | Traditional | PDF ↗ |
| K113747 | RANDOX OPIATES ASSAY | Randox Laboratories Limited | 2012-08-24 | Traditional | PDF ↗ |
| K120763 | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS | Lin-Zhi International, Inc. | 2012-06-01 | Traditional | PDF ↗ |
| K120761 | LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS | Lin-Zhi International, Inc. | 2012-05-08 | Traditional | PDF ↗ |
| K111926 | PSYCHEMEDICS OPIATES EIA | Psychemedics Corp. | 2012-05-01 | Traditional | PDF ↗ |
| K113624 | WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2012-03-12 | Traditional | PDF ↗ |
| K103161 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES | Omega Laboratories, Inc. | 2011-12-13 | Traditional | PDF ↗ |
| K112310 | WONDFO METHADONE URINE TEST,OPIATE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-08 | Traditional | PDF ↗ |
| K110298 | OPIATE ENZYME IMMUNOASSAY | Lin-Zhi International, Inc. | 2011-07-15 | Traditional | PDF ↗ |
| K101754 | THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY | Microgenics Corp. | 2011-04-08 | Traditional | PDF ↗ |
| K102779 | EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C | Siemens Healthcare Diagnostics, Inc. | 2011-03-18 | Traditional | PDF ↗ |
| K093867 | ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A | Roche Diagnostics | 2011-02-11 | Traditional | PDF ↗ |
| K100951 | MEDTOX BUPRENORPHINE TEST | Medtox Diagnostics, Inc. | 2010-10-18 | Traditional | PDF ↗ |
| K093175 | WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES | Guangzhou Wondfo Biotech Co., Ltd. | 2010-08-25 | Traditional | PDF ↗ |
| K100051 | INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) | Alfa Scientific Designs, Inc. | 2010-07-06 | Abbreviated | PDF ↗ |
| K101195 | 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2010-07-06 | Traditional | PDF ↗ |
| K100023 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM | Medtox Diagnostics, Inc. | 2010-04-05 | Traditional | PDF ↗ |
| K091612 | UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; | Ucp Biosciences, Inc. | 2010-02-24 | Traditional | PDF ↗ |
| K090844 | BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2009-07-30 | Traditional | PDF ↗ |
| K091454 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM | Medtox Diagnostics, Inc. | 2009-07-24 | Traditional | PDF ↗ |
| K081008 | BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS | Lin-Zhi International, Inc. | 2008-12-22 | Traditional | PDF ↗ |
| K082508 | FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD | Branan Medical Corporation | 2008-11-21 | Traditional | PDF ↗ |
| K063699 | IMDX SYSTEMS | Novx Systems, Inc. | 2007-06-01 | Traditional | PDF ↗ |
| K063545 | MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE | Alfa Scientific Designs, Inc. | 2007-05-07 | Abbreviated | PDF ↗ |
| K063015 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 | Ameditech, Inc. | 2006-12-20 | Traditional | PDF ↗ |
| K062460 | VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | 2006-12-15 | Traditional | PDF ↗ |
| K060760 | RAPIDONE-BUPRENORPHINE TEST | American Bio Medica Corp. | 2006-08-07 | Traditional | PDF ↗ |
| K060527 | INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST | Alfa Scientific Designs, Inc. | 2006-07-25 | Abbreviated | PDF ↗ |
| K051958 | MP RAPIDOXY TEST STRIP, MODEL 07RD-7073 | Mp Biomedicals, LLC | 2006-07-21 | Traditional | PDF ↗ |
| K053037 | ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 | Acro Biotech, LLC | 2006-06-15 | Traditional | PDF ↗ |
Product code DJG · Class II · Clinical Toxicology. Data: openFDA.