Product code DJG— Clinical Toxicology
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
- Classification name
- Enzyme Immunoassay, Opiates
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Total cleared
- 215
- First cleared
- Most recent
Market context for product code DJG
FDA has cleared devices under product code DJG between 1984 and 2026, filed by 86 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code DJG
Recent clearances under product code DJG
1–100 of 215- K252684 — Labcorp Fentanyl Urine Visual Test
- K250741 — Evidence MultiSTAT DOA Urine MultiPlex
- K253082 — LZI Buprenorphine II Enzyme Immunoassay
- K252520 — SEFRIA Hydrocodone Oral Fluid
- K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative +1 more
- K251634 — LZI Fentanyl III Enzyme Immunoassay
- K240124 — BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
- K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx
- K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
- 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
- K232597 — LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
- 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
- K232659 — Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
- K231752 — ARK Hydrocodone Assay
- K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
- K221550 — Evidence MultiSTAT DOA Urine MultiPlex
- K231007 — CEDIA Heroin Metabolite (6-AM) Assay
- K231698 — AllTest Fentanyl Rapid Test (Urine)
- K221605 — Emit® II Plus Buprenorphine Assay
- K230238 — BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx
- K222955 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
- K220046 — Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
- K203527 — Immunalysis Tapentadol Urine HEIA
- K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
- K201630 — AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
- K201326 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
- K201494 — ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
- K202007 — LZI Oxycodone III Enzyme Immunoassay
- K201938 — LZI Fentanyl II Enzyme Immunoassay
- K201223 — LZI Tramadol Enzyme Immunoassay
- K200197 — ARK Fentanyl II Assay
- K192943 — CEDIA Heroin Metabolite (6-AM) assay
- K182103 — Psychemedics Microplate EIA for Fentanyl in Hair
- K182123 — ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
- K182280 — ARK Tramadol Assay
- K181159 — LZI Fentanyl Enzyme Immunoassay
- K180427 — ARK Fentanyl Assay
- K172416 — Synermed Opiate Enzyme Immunoassay
- K173195 — DRI Hydrocodone Assay
- K173183 — CEDIA Heroin Metabolite (6-AM) Assay
- K172910 — Emit II Plus Oxycodone Assay
- K161216 — Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
- K163101 — CEDIA Buprenorphine II Assay +3 more
- K153050 — Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
- K153192 — Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
- 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.
- 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
- K150502 — DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
- K151478 — Wondfo CR3 Keyless Split Sample Cup
- K143502 — Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
- K143599 — Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000
- K150275 — Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls
- K150179 — CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
- K141205 — LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
- K141803 — IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
- K143187 — Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
- K140671 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE
- K142280 — Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
- K142396 — Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
- K140748 — ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
- K141406 — IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
- K141055 — LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)
- K140089 — CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
- K130650 — STATUS DS OXY
- K133642 — RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK
- K131168 — IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
- K130275 — QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
- K122064 — FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
- K130665 — WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
- K130055 — ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
- K123799 — PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
- K113747 — RANDOX OPIATES ASSAY
- K120763 — LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
- K120761 — LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
- K111926 — PSYCHEMEDICS OPIATES EIA
- K113624 — WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
- K103161 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES
- K112310 — WONDFO METHADONE URINE TEST,OPIATE TEST
- K110298 — OPIATE ENZYME IMMUNOASSAY
- K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
- K102779 — EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C
- K093867 — ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
- K100951 — MEDTOX BUPRENORPHINE TEST
- K093175 — WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES
- K100051 — INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
- K101195 — 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS
- K100023 — PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
- K091612 — UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST
- K090844 — BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
- K091454 — PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
- K081008 — BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
- K082508 — FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD
- K063699 — IMDX SYSTEMS
- K063545 — MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
- K063015 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150
- K062460 — VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III
- K060760 — RAPIDONE-BUPRENORPHINE TEST
- K060527 — INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST
- K051958 — MP RAPIDOXY TEST STRIP, MODEL 07RD-7073
- K053037 — ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
Data sourced from openFDA. This site is unofficial and independent of the FDA.