Enzyme Immunoassay, Opiates

K number K252684

DJG 2026-01-23

Evidence MultiSTAT DOA Urine MultiPlex

K number K250741

DJG 2026-01-16

LZI Buprenorphine II Enzyme Immunoassay

K number K253082

DJG 2025-09-11

SEFRIA™ Hydrocodone Oral Fluid

Applicant Immunalysis Corporation

K number K252520

DJG 2025-08-15

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

Applicant Healgen Scientific,, LLC

K number K251972

DJG 2025-06-18

LZI Fentanyl III Enzyme Immunoassay

K number K251634

DJG 2024-06-14

BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K number K240124

DJG 2024-05-10

Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K number K240698

DJG 2024-03-08

Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard

Applicant Co-Innovation Biotech Co., Ltd.

K number K231904

DJG 2024-02-23

Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card

Applicant Shanghai Accurature Diagnostics Co., Ltd.

K number K232228

DJG 2024-01-09

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

Applicant Hangzhou Laihe Biotech Co., Ltd.

K number K232597

DJG 2023-12-20

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

Applicant Chemtron Biotech, Inc.

K number K232736

DJG 2023-12-13

Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K number K232659

DJG 2023-11-09

ARK Hydrocodone Assay

Applicant Ark Diagnostics, Inc.

K number K231752

DJG 2023-10-05

Evidence MultiSTAT DOA Urine MultiPlex

K number K221550

DJG 2023-10-05

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT

K number K220451

DJG 2023-09-27

CEDIA Heroin Metabolite (6-AM) Assay

Applicant Microgenics Corporation

K number K231007

DJG 2023-07-31

AllTest Fentanyl Rapid Test (Urine)

Applicant Hangzhou AllTest Biotech Co., Ltd.

K number K231698

DJG 2023-07-25

Emit® II Plus Buprenorphine Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K number K221605

DJG 2023-03-31

BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx

Applicant Shenzhen Bioeasy Biotechnology Co., Ltd.

K number K230238

DJG 2023-02-06

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

Applicant Xenta Biomedical Science Co., Ltd.

K number K222955

DJG 2022-12-13

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11

Applicant Shenzhen Superbio Technology Co., Ltd.

K number K220046

DJG 2022-05-09

Immunalysis Tapentadol Urine HEIA

Applicant Lmmunalysis Corporation

K number K203527

DJG 2021-12-22

SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay

Applicant Immunalysis Corporation

K number K203564

DJG 2021-08-12

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

Applicant Assure Tech. (Hangzhou) Co, Ltd.

K number K201630

DJG 2021-07-27

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair

Applicant Psychemedics Corporation

K number K201326

DJG 2020-09-17

LZI Oxycodone III Enzyme Immunoassay

K number K202007

DJG 2020-09-17

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

Applicant Advin Biotech, Inc.

K number K201494

DJG 2020-08-07

LZI Fentanyl II Enzyme Immunoassay

K number K201938

DJG 2020-06-04

LZI Tramadol Enzyme Immunoassay

K number K201223

DJG 2020-02-26

ARK Fentanyl II Assay

Applicant Ark Diagnostics, Inc.

K number K200197

DJG 2019-12-16

CEDIA Heroin Metabolite (6-AM) assay

Applicant Microgenics Corporation

K number K192943

DJG 2019-04-18

Psychemedics Microplate EIA for Fentanyl in Hair

Applicant Psychemedics Corporation

K number K182103

DJG 2019-03-29

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

Applicant Advin Biotech, Inc.

K number K182123

DJG 2018-12-10

ARK Tramadol Assay

Applicant Ark Diagnostics, Inc.

K number K182280

DJG 2018-12-03

LZI Fentanyl Enzyme Immunoassay

K number K181159

DJG 2018-06-06

ARK Fentanyl Assay

Applicant Ark Diagnostics, Inc.

K number K180427

DJG 2018-04-19

Synermed Opiate Enzyme Immunoassay

Applicant Infrared Laboratory Systems, LLC (Dba Synermed)

K number K172416

DJG 2018-02-13

DRI Hydrocodone Assay

Applicant Microgenics Corporation

K number K173195

DJG 2017-11-22

CEDIA Heroin Metabolite (6-AM) Assay

Applicant Microgenics Corporation

K number K173183

DJG 2017-10-18

Emit II Plus Oxycodone Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K number K172910

DJG 2017-06-14

Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators

Applicant Immunalysis Corporation

K number K161216

DJG 2017-04-06

CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set

Applicant Microgenics Corporation

K number K163101

DJG 2016-04-26

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard

Applicant Co-Innovation Biotech Co., Ltd.

K number K153050

DJG 2016-04-18

Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests

Applicant Chemtron Biotech, Inc.

K number K153192

DJG 2013-09-26

QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST

K number K130275

DJG 2013-05-07

FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE

K number K122064

DJG 2013-04-09

WONDOFO MULTI-DRUG URINE TEST CUP / PANEL

K number K130665

DJG 2013-02-14

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP

K number K130055

DJG 2013-02-08

PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR

Applicant Psychemedics Corp.

K number K123799

DJG 2012-08-24

RANDOX OPIATES ASSAY

K number K113747

DJG 2012-06-01

LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS

K number K120763

DJG 2012-05-08

LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS

K number K120761

DJG 2012-05-01

PSYCHEMEDICS OPIATES EIA

Applicant Psychemedics Corp.

K number K111926

DJG 2012-03-12

WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST

K number K113624

DJG 2011-12-13

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES

Applicant Omega Laboratories, Inc.

K number K103161

DJG 2011-09-08

WONDFO METHADONE URINE TEST,OPIATE TEST

K number K112310

DJG 2011-07-15

OPIATE ENZYME IMMUNOASSAY

K number K110298

DJG 2011-04-08

THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY

Applicant Microgenics Corp.

K number K101754

DJG 2011-03-18

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

Applicant Siemens Healthcare Diagnostics, Inc.

K number K102779

DJG 2011-02-11

ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A

Applicant Roche Diagnostics

K number K093867

DJG 2010-10-18

MEDTOX BUPRENORPHINE TEST

K number K100951

DJG 2010-08-25

WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES

K number K093175

DJG 2010-07-06

6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS

K number K101195

DJG 2010-07-06

INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)

Applicant Alfa Scientific Designs, Inc.

K number K100051

DJG 2010-04-05

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM

K number K100023

DJG 2010-02-24

UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;

Applicant Ucp Biosciences, Inc.

K number K091612

DJG 2009-07-30

BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS

K number K090844

DJG 2009-07-24

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM

K number K091454

DJG 2008-12-22

BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS

K number K081008

DJG 2008-11-21

FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD

Applicant Branan Medical Corporation

K number K082508

DJG 2007-06-01

IMDX SYSTEMS

Applicant Novx Systems, Inc.

K number K063699

DJG 2007-05-07

MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE

Applicant Alfa Scientific Designs, Inc.

K number K063545

DJG 2006-12-20

AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150

Applicant Ameditech, Inc.

K number K063015

DJG 2006-12-15

VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III

Applicant Ortho-Clinical Diagnostics, Inc.

K number K062460

DJG 2006-08-07

RAPIDONE-BUPRENORPHINE TEST

Applicant American Bio Medica Corp.

K number K060760

DJG 2006-07-25

INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST

Applicant Alfa Scientific Designs, Inc.

K number K060527

DJG 2006-07-21

MP RAPIDOXY TEST STRIP, MODEL 07RD-7073

Applicant Mp Biomedicals, LLC

K number K051958

DJG 2006-06-15

ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100

Applicant Acro Biotech, LLC

K number K053037

DJG 2006-05-12

MEDTOX OXYCODONE

K number K060351

DJG 2006-04-24

RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC

K number K052520

DJG 2006-04-21

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K060466

DJG 2005-10-13

IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS

Applicant Immunalysis Corporation

K number K051626

DJG 2005-07-06

QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)

Applicant Quest Diagnostics, Inc.

K number K042725

DJG 2005-06-13

OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS

K number K050733

DJG 2005-05-12

RAPID ONE STEP BUPRENORPHINE TEST CARD

K number K042988

DJG 2005-05-10

FOR SURE ONE STEP BUPRENORPHINE TEST STRIP

K number K042990

DJG 2005-02-25

ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K043507

DJG 2005-02-07

QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121

Applicant Phamatech, Inc.

K number K043051

DJG 2004-11-24

IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)

Applicant Lifepoint,Inc

K number K041747

DJG 2004-11-23

IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)

Applicant Lifepoint,Inc

K number K041746

DJG 2004-11-03

RANDOX OPIATES ASSAY

Applicant Randox Laboratories, Ltd.

K number K041144

DJG 2004-06-23

CEDIA BUPRENORPHINE ASSAY

Applicant Microgenics Corp.

K number K040316

DJG 2004-05-03

ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K040274

DJG 2004-02-17

ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K033047

DJG 2003-07-14

VERDICT II, PROFILE II

K number K031032

DJG 2003-07-02

MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23

Applicant Branan Medical Corp.

K number K030113

DJG 2003-04-29

SYNCHRON SYSTEMS OPIATE REAGENT

Applicant Beckman Coulter, Inc.

K number K031002

DJG 2002-11-06

AMEDICA DRUG SCREEN OPIATES TEST

Applicant Amedica Biotech, Inc.

K number K023047

DJG 2002-11-05

COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE

Applicant Cozart Bioscience , Ltd.

K number K020920