FDA.reportPublic FDA data

Amphetamine-specific 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 a specific amphetamine in a clinical specimen, using an enzyme immunoassay (EIA) method.
GUDID devices
57
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414654171Atellica CH Amphetamine (AmpC)Siemens Healthcare Diagnostics Inc.117013242025-10-15
00840937112007ImmunalysisIMMUNALYSIS CORP609OF-01002023-10-25
00840937112014ImmunalysisIMMUNALYSIS CORP609OF-05002023-10-25
00811727016539Pointe Amphetamines 500 Reagent SetHORIBA INSTRUMENTS INCORPORATED60-AM0200-1002020-09-25
00811727016546Pointe Amphetamines 500 Reagent SetHORIBA INSTRUMENTS INCORPORATED60-AM0200-1L2020-09-25
00811727016614Pointe Amphetamines 1000 Reagent SetHORIBA INSTRUMENTS INCORPORATED60-AM0080-1002020-09-25
00811727016621Pointe Amphetamines 1000 Reagent SetHORIBA INSTRUMENTS INCORPORATED60-AM0080-1L2020-09-25
00811727017994Pointe Ecstasy (MDMA) Reagent SetHORIBA INSTRUMENTS INCORPORATED60-EC0320-1002020-09-25
00811727018007Pointe Ecstasy (MDMA) Reagent SetHORIBA INSTRUMENTS INCORPORATED60-EC0320-1L2020-09-25
00840937100134Immunalysis CorporationIMMUNALYSIS CORPORATION209-01922016-08-31
00840937100141Immunalysis CorporationIMMUNALYSIS CORPORATION209-04802016-08-31
00840937100158Immunalysis CorporationIMMUNALYSIS CORPORATION209-48002016-08-31
00840937101629Immunalysis CorporationIMMUNALYSIS CORPORATION309-00252016-08-31
00840937101636Immunalysis CorporationIMMUNALYSIS CORPORATION309-0025EX2016-08-31
00840937101643Immunalysis CorporationIMMUNALYSIS CORPORATION309-01002016-08-31
00840937101650Immunalysis CorporationIMMUNALYSIS CORPORATION309-0100EX2016-08-31
00840937101667Immunalysis CorporationIMMUNALYSIS CORPORATION309-05002016-08-31
00840937101674Immunalysis CorporationIMMUNALYSIS CORPORATION309-0500EX2016-08-31
00840937101681ImmunalysisIMMUNALYSIS CORP309UR-00252016-08-31
00840937101704ImmunalysisIMMUNALYSIS CORP309UR-0060W2016-08-31
00840937101728ImmunalysisIMMUNALYSIS CORP309UR-01002016-08-31
00840937101742ImmunalysisIMMUNALYSIS CORP309UR-05002016-08-31
00840937105191ImmunalysisIMMUNALYSIS CORPASR-A-309-1002016-08-31
00840937105207ImmunalysisIMMUNALYSIS CORPASR-A-309-10002016-08-31
00840937106082ImmunalysisIMMUNALYSIS CORPASR-E-309-602016-08-31
00840937106099ImmunalysisIMMUNALYSIS CORPASR-E-309-6002016-08-31
00840937109649Immunalysis CorporationIMMUNALYSIS CORPORATION309-0060W2017-01-13
00840937109656Immunalysis CorporationIMMUNALYSIS CORPORATION309-0060WEX2017-01-13
00840937109793Immunalysis CorporationIMMUNALYSIS CORPORATION209-0192EX2017-04-18
00840937109809Immunalysis CorporationIMMUNALYSIS CORPORATION209-0480EX2017-04-18
00840937109816Immunalysis CorporationIMMUNALYSIS CORPORATION209-4800EX2017-04-18
B076S0040B0Oral Fluid Amphetamine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.S0040b2016-07-05
B076S0041B0Oral Fluid Amphetamine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.S0041b2016-07-05
00842768005817Dimension® Flex® reagent cartridge AMPHSiemens Healthcare Diagnostics Inc.104449262016-09-24
00842768015052Dimension Vista® Flex® reagent cartridge AMPHSiemens Healthcare Diagnostics Inc.104451122016-09-24
00853691007113AMP Rapid Test CassetteACRO BIOTECH INC12017-06-28
00884883000209CEDIA Amphetamine OFT AssayMicrogenics Corporation100185792016-09-22
00884883000841CEDIA Amphetamine OFT AssayMicrogenics Corporation100217292016-10-03
00884883001534CEDIA Amphetamines/Ecstasy AssayMicrogenics Corporation1001032016-09-12
00884883001541CEDIA Amphetamines/Ecstasy AssayMicrogenics Corporation1001042016-09-24
00884883002524DRI Amphetamines AssayMicrogenics Corporation00172016-09-22
00884883002821DRI Amphetamines AssayMicrogenics Corporation00182016-09-22
00884883004085CEDIA Amphetamines/Ecstasy Microgenics Corporation1000402016-09-12
00884883004665DRI Amphetamines AssayMicrogenics Corporation100145852016-09-22
00884883011069CEDIA Amphetamine OFT AssayMicrogenics Corporation100149472016-09-22
00884883012523CEDIA Amphetamine/Ecstasy AssayMicrogenics Corporation100164172016-10-25
00817302021028CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT MR412CAROLINA LIQUID CHEMISTRIES CORPORATIONMR4122016-09-01
00817302021035CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT ST412CAROLINA LIQUID CHEMISTRIES CORPORATIONST4122016-09-01
00817302021042CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT ST312CAROLINA LIQUID CHEMISTRIES CORPORATIONST3122016-09-01
00817302021059CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT BL-412CAROLINA LIQUID CHEMISTRIES CORPORATIONBL4122016-09-01
00817302021066CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT AU-412CAROLINA LIQUID CHEMISTRIES CORPORATIONAU-4122016-09-01
00817302021073CAROLINA LIQUID CHEMISTRIES CORP.™ AMPH AMPHETAMINE CC412CAROLINA LIQUID CHEMISTRIES CORPORATIONCC4122016-09-01
00817302021813CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT KIT Product No. DT412CAROLINA LIQUID CHEMISTRIES CORPORATIONDT4122016-09-01
00630414568744ADVIA® Chemistry AMPH_2 Amphetamines_2 ReagentsSiemens Healthcare Diagnostics Inc.103787582016-09-24
00630414596068Atellica CH AmpSiemens Healthcare Diagnostics Inc.110975062017-12-22
00608337000146Amphetamine Intercept 5 Plate KitOrasure Technologies, Inc.1103IB2016-09-12
00608337000153Amphetamine Intercept 100 Plate KitOrasure Technologies, Inc.1103IC2016-09-12