Enzyme Immunoassay, Methadone

FDA product code DJR · 60 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3620
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1984-03-19 – 2019-10-04

DJR 2019-10-04

LZI Methadone II Enzyme Immunoassay

Applicant Lin-Zhi International, Inc.

K number K192433

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DJR 2018-11-21

ARK EDDP Assay

Applicant Ark Diagnostics, Inc.

K number K182779

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DJR 2017-06-26

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators

Applicant Lin-Zhi International, Inc.

K number K170416

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DJR 2016-08-17

First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)

Applicant W.H.P.M., Inc.

K number K160793

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DJR 2013-05-31

WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K number K131232

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DJR 2010-11-18

RANDOX METHADONE ASSAY

Applicant Randox Laboratories, Ltd.

K number K092272

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DJR 2010-11-09

RANDOX METABOLITE (EDDP) ASSAY

Applicant Randox Laboratories, Ltd.

K number K092258

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DJR 2010-04-19

ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP

Applicant Biosite Incorporated

K number K092048

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DJR 2009-01-14

DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS

Applicant Thermo Fisher Scientific

K number K081378

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DJR 2006-11-22

VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V

Applicant Ortho-Clinical Diagnostics, Inc.

K number K062637

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DJR 2006-06-22

TRIAGE TOX DRUG SCREEN, MODEL 94400

Applicant Biosite Incorporated

K number K060791

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DJR 2006-06-09

FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST

Applicant W.H.P.M., Inc.

K number K052197

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DJR 2006-03-29

METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS

Applicant Lin-Zhi International, Inc.

K number K051058

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DJR 2004-05-10

RANDOX METHADONE ASSAY

Applicant Randox Laboratories, Ltd.

K number K040570

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DJR 2003-10-10

METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)

Applicant Lin-Zhi International, Inc.

K number K031797

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DJR 2003-08-27

DRI METHADONE METABOLITE ENZYME IMMUNOASSAY

Applicant Microgenics Corp.

K number K023617

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DJR 2003-08-25

VISUALINE METHADONE DIPSTRIPTEST

Applicant Sun Biomedical Laboratories, Inc.

K number K023856

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DJR 2003-04-30

'RAPIDTEC'-5M-MULTIPLE DIP TEST

Applicant American Bio Medica Corp.

K number K023869

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DJR 2002-12-12

METHADONE ENZYME IMMUNOASSAY

Applicant Lin-Zhi International, Inc.

K number K023317

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DJR 2002-11-22

RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020

Applicant Icn Biomedicals, Inc.

K number K023252

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DJR 2002-07-16

COBAS INTEGRA ONLINE DAT II METHADONE II

Applicant Roche Diagnostics Corp.

K number K021512

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DJR 2002-07-16

ONLINE DAT II METHADONE II

Applicant Roche Diagnostics Corp.

K number K021505

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DJR 2002-03-20

METHADONE

Applicant Abbott Laboratories

K number K013001

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DJR 2001-11-26

LIVESURE METHADONE SCREEN TESTS

Applicant Pan Probe Biotech, Inc.

K number K013796

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DJR 2001-11-20

'RAPIDONE'-METHADONE TEST

Applicant American Bio Medica Corp.

K number K012164

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DJR 2001-10-15

ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K012595

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DJR 2001-07-31

METHADONE MICROPLATE EIA URINE APPLICATION

Applicant Cozart Bioscience , Ltd.

K number K011131

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DJR 2001-05-29

INSTANT-VIEW METHADONE URINE CASSETTE TEST

Applicant Alfa Scientific Designs, Inc.

K number K010015

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DJR 2001-05-29

INSTANT-VIEW METHADONE URINE DIP STRIP TEST

Applicant Alfa Scientific Designs, Inc.

K number K010014

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DJR 2001-04-26

EMIT II PLUS METHADONE ASSAY, MODEL OSRE229

Applicant Syva Co., Dade Behring, Inc.

K number K010962

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DJR 2000-11-29

STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421

Applicant OraSure Technologies, Inc.

K number K002010

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DJR 2000-11-22

BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D

Applicant Branan Medical Corporation

K number K002417

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DJR 2000-04-05

URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A

Applicant Dade Behring, Inc.

K number K000466

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DJR 2000-01-20

SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL

Applicant Syva Co.

K number K994005

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DJR 1999-04-15

ACCUSIGN MTD, BIOSIGN MTD

Applicant Princeton BioMeditech Corp.

K number K991080

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DJR 1999-02-05

QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153

Applicant Phamatech

K number K982938

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DJR 1998-12-11

MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE

Applicant Roche Diagnostic Systems, Inc.

K number K983703

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DJR 1998-09-04

VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE

Applicant Sun Biomedical Laboratories, Inc.

K number K981314

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DJR 1998-05-26

CEDIA DAU EDDP ASSAY

Applicant Boehringer Mannheim Corp.

K number K980746

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DJR 1997-09-22

SYNCHRON SYSTEMS METHADONE REAGENT

Applicant Beckman Instruments, Inc.

K number K973069

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DJR 1997-08-04

METHADONE EIA ASSAY

Applicant Diagnostic Reagents, Inc.

K number K972526

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DJR 1996-08-15

ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY

Applicant Princeton BioMeditech Corp.

K number K962673

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DJR 1995-11-17

CEDIA DAU METHADONE ASSAY

Applicant Microgenics Corp.

K number K954227

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DJR 1995-11-13

AXSYM METHADONE

Applicant Abbott Laboratories

K number K953499

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DJR 1994-12-29

AUTO-LYTE METHADONE DIA

Applicant Solarcare Technologies Corp,Inc.

K number K944056

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DJR 1994-12-02

CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST

Applicant Beckman Instruments, Inc.

K number K944074

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DJR 1994-01-26

METHADONE ENZYME IMMUNOASSAY

Applicant Diagnostic Reagents, Inc.

K number K934667

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DJR 1993-11-09

DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K934147

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DJR 1993-09-24

ROCHE ABUSCREEN ONLINE FOR METHADONE

Applicant Roche Diagnostic Systems, Inc.

K number K930928

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DJR 1993-08-23

METHADONE METABOLITE EIA ASSAY

Applicant Diagnostic Reagents, Inc.

K number K931780

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DJR 1992-04-24

IL TEST METHADONE

Applicant Instrumentation Laboratory CO

K number K920858

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DJR 1992-03-13

SYVA EMIT II METHADONE ASSAY

Applicant Syva Co.

K number K920751

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DJR 1991-05-23

REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION

Applicant Bio-Rad

K number K911954

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DJR 1988-12-16

TDX METHADONE ASSAY

Applicant Abbott Laboratories

K number K884968

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DJR 1987-10-28

REVISED LABELING FOR SYVA METHADONE ASSAYS

Applicant Syva Co.

K number K873899

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DJR 1987-10-15

LABELING CHANGES COAT-A-COUNT METHADONE IN URINE

Applicant Diagnostic Products Corp.

K number K873750

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DJR 1987-03-19

COAT-A-COUNT METHADONE TKMD1

Applicant Diagnostic Products Corp.

K number K870937

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DJR 1985-04-01

EMIT 700 METHADONE ASSAY

Applicant Syva Co.

K number K850953

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DJR 1984-09-26

EMIT D.A.U. METHADONE ASSAY

Applicant Syva Co.

K number K842676

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DJR 1984-03-19

EMIT ST URINE METHADONE ASSAY

Applicant Syva Co.

K number K840060

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