FDA.reportPublic FDA data

Ethyl glucuronide (EtG) IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of ethyl glucuronide (EtG), a metabolite of ethanol alcohol (ETOH), in a clinical specimen.
GUDID devices
24
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04250317544742Urine ControlChromsystems Instruments + Chemicals GmbH03672020-08-06
04250317546067Urine ControlChromsystems Instruments + Chemicals GmbH03682020-08-06
04250317546111Urine ControlChromsystems Instruments + Chemicals GmbH03692020-08-06
B800130200ETG Plus Level 1UTAK LABORATORIES, INC.130202020-04-15
B800130210ETG Plus Level 2UTAK LABORATORIES, INC.130212020-04-15
04250317535771Urine ControlChromsystems Instruments + Chemicals GmbH03672020-08-06
04250317535788Urine ControlChromsystems Instruments + Chemicals GmbH03682020-08-06
04250317535795Urine ControlChromsystems Instruments + Chemicals GmbH03692020-08-06
B800130205ETG Plus Level 1UTAK LABORATORIES, INC.130202020-04-15
B800130215ETG Plus Level 2UTAK LABORATORIES, INC.130212020-04-15
00840937104002Immunalysis CorporationIMMUNALYSIS CORPORATIONC341-10-2-10002016-08-31
00840937104019Immunalysis CorporationIMMUNALYSIS CORPORATIONC341-10-2-1000EX2016-08-31
00840937104026Immunalysis CorporationIMMUNALYSIS CORPORATIONC341-10-2-5002016-08-31
00840937104033Immunalysis CorporationIMMUNALYSIS CORPORATIONC341-10-2-500EX2016-08-31
00840937110409ImmunalysisIMMUNALYSIS CORP3010-52017-09-07
00840937110669ImmunalysisIMMUNALYSIS CORPC341UR-5-2-5002017-10-24
00840937110676ImmunalysisIMMUNALYSIS CORPC341UR-5-2-10002017-10-24
00850004812198DetectabuseBIOCHEMICAL DIAGNOSTICS INC19900100-2pk2020-01-20
00850004812525DetectabuseBIOCHEMICAL DIAGNOSTICS INC19900025-2pk2020-01-20
00850004812532DetectabuseBIOCHEMICAL DIAGNOSTICS INC19900050-2pk2020-01-20
00858724003490ARK™ Ethyl Glucuronide Control (375/625)ARK DIAGNOSTICS INC5036-0003-002018-01-29
00858724003506ARK™ Ethyl Glucuronide Control (750/1250)ARK DIAGNOSTICS INC5036-0003-012017-12-25
00858724003759ARK™ Ethyl Glucuronide Control (375/625)ARK DIAGNOSTICS INC5036-0006-002018-09-12
00858724003766ARK™ Ethyl Glucuronide Control (750/1250)ARK DIAGNOSTICS INC5036-0006-012018-09-12