FDA.reportPublic FDA data

Methadone IVD, kit, enzyme immunoassay (EIA)

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of methadone in a clinical specimen, using an enzyme immunoassay (EIA) method.
GUDID devices
58
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414654294Atellica CH Methadone (MdnC)Siemens Healthcare Diagnostics Inc.117013312025-10-15
10758750001828VITROSORTHO-CLINICAL DIAGNOSTICS, INC.68019962016-08-26
B07606300LZI Methadone II Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.06302021-05-03
B07606310LZI Methadone II Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.06312021-05-03
00811727017024Pointe Methadone Reagent SetHORIBA INSTRUMENTS INCORPORATED60-ME0220-1002020-09-25
00811727017031Pointe Methadone Reagent SetHORIBA INSTRUMENTS INCORPORATED60-ME0220-1L2020-09-25
00840937100707Immunalysis CorporationIMMUNALYSIS CORPORATION232-00962016-08-31
00840937100714Immunalysis CorporationIMMUNALYSIS CORPORATION232-04802016-08-31
00840937100721Immunalysis CorporationIMMUNALYSIS CORPORATION232-48002016-08-31
00840937100981Immunalysis CorporationIMMUNALYSIS CORPORATION301-00252016-08-31
00840937100998Immunalysis CorporationIMMUNALYSIS CORPORATION301-0025EX2016-08-31
00840937101001Immunalysis CorporationIMMUNALYSIS CORPORATION301-0060W2016-08-31
00840937101018Immunalysis CorporationIMMUNALYSIS CORPORATION301-0060WEX2016-08-31
00840937101025Immunalysis CorporationIMMUNALYSIS CORPORATION301-01002016-08-31
00840937101032Immunalysis CorporationIMMUNALYSIS CORPORATION301-0100EX2016-08-31
00840937101049Immunalysis CorporationIMMUNALYSIS CORPORATION301-05002016-08-31
00840937101056Immunalysis CorporationIMMUNALYSIS CORPORATION301-0500EX2016-08-31
00840937102473Immunalysis CorporationIMMUNALYSIS CORPORATION332-00252016-08-31
00840937102480Immunalysis CorporationIMMUNALYSIS CORPORATION332-01002016-08-31
00840937102497Immunalysis CorporationIMMUNALYSIS CORPORATION332-05002016-08-31
00840937109113ImmunalysisIMMUNALYSIS CORPASR-A-332-1002017-01-11
00840937109120ImmunalysisIMMUNALYSIS CORPASR-A-332-10002017-01-11
00840937109434ImmunalysisIMMUNALYSIS CORPASR-E-332-602017-01-12
00840937109441ImmunalysisIMMUNALYSIS CORPASR-E-332-6002017-01-12
00840937109762Immunalysis CorporationIMMUNALYSIS CORPORATION332-0060W2017-01-13
00840937109953Immunalysis CorporationIMMUNALYSIS CORPORATION232-0096EX2017-05-15
00840937109960Immunalysis CorporationIMMUNALYSIS CORPORATION232-0480EX2017-05-15
00840937109977Immunalysis CorporationIMMUNALYSIS CORPORATION232-4800EX2017-05-15
00380740165253AlinityABBOTT LABORATORIES09P64202019-09-12
15099590222994SynchronBeckman Coulter, Inc.4750182016-08-24
B07601100Methadone Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.01102016-07-05
B07601110Methadone Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.01112016-07-05
00842768000133Syva® Emit® II Plus Methadone AssaySiemens Healthcare Diagnostics Inc.104454262016-09-24
00842768000157Syva® Emit® II Plus Methadone AssaySiemens Healthcare Diagnostics Inc.104454282016-09-24
00842768005800Dimension® Flex® reagent cartridge METHSiemens Healthcare Diagnostics Inc.104449222016-09-24
00842768014369Syva® Emit® II Plus Methadone AssaySiemens Healthcare Diagnostics Inc.104454272016-09-24
00842768015304Dimension Vista® Flex® reagent cartridge METHSiemens Healthcare Diagnostics Inc.104451112016-09-24
00842768023385Emit® II Plus Methadone AssaySiemens Healthcare Diagnostics Inc.104452312016-09-24
00884883001442CEDIA Methadone AssayMicrogenics Corporation1000882016-09-12
00884883001503CEDIA Methadone AssayMicrogenics Corporation1000972016-09-12
00884883002913DRI Methadone AssayMicrogenics Corporation05972016-09-06
00884883003392DRI Methadone AssayMicrogenics Corporation05962016-09-12
00884883004313CEDIA DAU MethadoneMicrogenics Corporation17309162016-10-25
00884883012493DRI Methadone AssayMicrogenics Corporation100164032016-09-12
00884883012547CEDIA Methadone AssayMicrogenics Corporation100164252016-09-12
00817302021417CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT. KIT MR415CAROLINA LIQUID CHEMISTRIES CORPORATIONMR4152016-09-01
00817302021424CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT. KIT ST415CAROLINA LIQUID CHEMISTRIES CORPORATIONST4152016-09-01
00817302021431CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT. KIT ST315CAROLINA LIQUID CHEMISTRIES CORPORATIONST3152016-09-01
00817302021448CAROLINA LIQUID CHEMISTRIES CORP.® EDDP REAGENT KIT Product No. DT426CAROLINA LIQUID CHEMISTRIES CORPORATIONDT4262016-09-01
00817302021455CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT. KIT AU-415CAROLINA LIQUID CHEMISTRIES CORPORATIONAU-4152016-09-01
00817302021462CAROLINA LIQUID CHEMISTRIES CORP.® METD METHADONE CC415CAROLINA LIQUID CHEMISTRIES CORPORATIONCC4152016-09-01
00817302021868CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT KIT Product No. DT415CAROLINA LIQUID CHEMISTRIES CORPORATIONDT4152016-09-01
00630414568782ADVIA® Chemistry MDN_2 Methadone_2 ReagentsSiemens Healthcare Diagnostics Inc.103787622016-09-24
00630414595917Atellica CH MdnSiemens Healthcare Diagnostics Inc.110975202017-12-22
00608337000320Methadone Intercept 5 Plate KitOrasure Technologies, Inc.1142IB2016-09-12
00608337000337Methadone Intercept 100 Plate KitOrasure Technologies, Inc.1142IC2016-09-12
00608337000344Methadone Intercept 2 Plate KitOrasure Technologies, Inc.1142IT2016-09-12
00380740005504ARCHITECTABBOTT LABORATORIES3L35-202016-06-06