FDA.reportPublic FDA data

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

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414654201Atellica CH Ecstasy (XtcC)Siemens Healthcare Diagnostics Inc.117013292025-10-15
00811727018304Pointe Methamphetamine Reagent SetHORIBA INSTRUMENTS INCORPORATED60-MP0700-1002020-09-25
00811727018311Pointe Methamphetamine Reagent SetHORIBA INSTRUMENTS INCORPORATED60-MP0700-1L2020-09-25
00840937100196Immunalysis CorporationIMMUNALYSIS CORPORATION211-01922016-08-31
00840937100202Immunalysis CorporationIMMUNALYSIS CORPORATION211-04802016-08-31
00840937100219Immunalysis CorporationIMMUNALYSIS CORPORATION211-48002016-08-31
00840937101841Immunalysis CorporationIMMUNALYSIS CORPORATION311-00252016-08-31
00840937101858Immunalysis CorporationIMMUNALYSIS CORPORATION311-0025EX2016-08-31
00840937101865Immunalysis CorporationIMMUNALYSIS CORPORATION311-01002016-08-31
00840937101872Immunalysis CorporationIMMUNALYSIS CORPORATION311-0100EX2016-08-31
00840937101889Immunalysis CorporationIMMUNALYSIS CORPORATION311-05002016-08-31
00840937101896Immunalysis CorporationIMMUNALYSIS CORPORATION311-0500EX2016-08-31
00840937101902ImmunalysisIMMUNALYSIS CORP311UR-00252016-08-31
00840937101926ImmunalysisIMMUNALYSIS CORP311UR-0060W2016-08-31
00840937101940ImmunalysisIMMUNALYSIS CORP311UR-01002016-08-31
00840937101964ImmunalysisIMMUNALYSIS CORP311UR-05002016-08-31
00840937105214ImmunalysisIMMUNALYSIS CORPASR-A-311-1002016-08-31
00840937105221ImmunalysisIMMUNALYSIS CORPASR-A-311-10002016-08-31
00840937106105ImmunalysisIMMUNALYSIS CORPASR-E-311-602016-08-31
00840937106112ImmunalysisIMMUNALYSIS CORPASR-E-311-6002016-08-31
00840937109663Immunalysis CorporationIMMUNALYSIS CORPORATION311-0060W2017-01-13
00840937109670Immunalysis CorporationIMMUNALYSIS CORPORATION311-0060WEX2017-01-13
00840937109823Immunalysis CorporationIMMUNALYSIS CORPORATION211-0192EX2017-04-18
00840937109830Immunalysis CorporationIMMUNALYSIS CORPORATION211-0480EX2017-04-18
00840937109847Immunalysis CorporationIMMUNALYSIS CORPORATION211-4800EX2017-04-18
00840937111291ImmunalysisIMMUNALYSIS CORP611OF-01002018-10-01
00840937111307ImmunalysisIMMUNALYSIS CORP611OF-05002018-10-01
B07603500Methamphetamine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.03502016-07-05
B07603510Methamphetamine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.03512016-07-05
B076S0050B0Oral Fluid Methamphetamine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.S0050b2016-07-05
B076S0051B0Oral Fluid Methamphetamine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.S0051b2016-07-05
00842768002229Syva® Emit® II Plus Ecstasy AssaySiemens Healthcare Diagnostics Inc.104454772016-09-24
00842768021947Syva® Emit® II Plus Ecstasy AssaySiemens Healthcare Diagnostics Inc.104454782016-09-24
00842768023460Emit® II Plus Ecstasy AssaySiemens Healthcare Diagnostics Inc.104454792016-09-24
00853691007649MET Rapid Test CassetteACRO BIOTECH INC12017-06-28
00853691007663MDMA Rapid Test CassetteACRO BIOTECH INC12017-06-28
00868586000278HairCheck-DT MethamphetamineQuest DiagnosticsPVD-Exempt2018-06-08
00884883000230CEDIA Methamphetamine OFT AssayMicrogenics Corporation100185952016-09-22
00884883000827CEDIA Methamphetamine OFT AssayMicrogenics Corporation100217532016-10-03
00884883011083CEDIA Methamphatemine OFT AssayMicrogenics Corporation100149492016-09-21
00630414595955Atellica CH XtcSiemens Healthcare Diagnostics Inc.110975182017-12-19
00608337000023Methamphetamine Intercept 2 Plate KitOrasure Technologies, Inc.1104IT2016-09-12
00608337000184Methamphetamine Intercept 5 Plate KitOrasure Technologies, Inc.1104IB2016-09-12
00608337000191Methamphetamine Intercept 100 Plate KitOrasure Technologies, Inc.1104IC2016-09-12