FDA.reportPublic FDA data

DRI Ethyl Alcohol Assay

Primary DI
00884883012486
Brand
DRI Ethyl Alcohol Assay
Company
Microgenics Corporation
Model
10016397
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DMTEnzymatic Method, Alcohol Dehydrogenase, UltravioletClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923783000ETHYL ALCOHOL ASSAYDiagnostic Reagents, Inc.1993-01-21DMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883012486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883012486008848830124868848830124860884883012486

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen, using an enzyme spectrophotometry method. It is typically used to assess for alcohol intoxication and in the management of alcoholism.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122153799
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884883009080MAS Immunology Advanced Sample PackICA-S12026-05-27
00884883011373MAS Immunology Advanced Level 1ICA-1012026-05-27
00884883011380MAS Immunology Advanced Level 2ICA-2022026-05-27
00884883011397MAS Immunology Advanced Level 3ICA-3032026-05-27
00884883011427CRP (C-Reactive Protein)75-54422026-05-27
00884883006751DRI Ecstasy Plus Assay100246312018-09-27
00884883001558CEDIA Heroin Metabolite (6-AM) Assay1001072016-09-26
00884883004245CEDIA Heroin Metabolite (6-AM) Assay1001082016-09-22
00884883004306CEDIA Heroin Metabolite (6-AM) Assay1001862016-09-21
00884883011366CEDIA Heroin Metabolite (6-AM) Assay100152132016-09-21
00884883009301MAS Omni•IMMUNE Max, Level 1OIMM-1012025-08-12
00884883009318MAS Omni•IMMUNE Max, Level 2OIMM-2022025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3OIMM-3032025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackOIMM-SP2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1OPROM-1012025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2OPROM-2022025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3OPROM-3032025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackOPROM-SP2025-08-12
00884883009257MAS OmniCORE Max, Level 1OCRM-1012025-06-27
00884883009264MAS OmniCORE Max, Level 2OCRM-2022025-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942284613443femometerJOYTECH HEALTHCARE CO.,LTDDMT2026-05-25
00380740135393AlinityABBOTT LABORATORIESDMT2019-04-16
00380740135386AlinityABBOTT LABORATORIESDMT2018-07-11
00884883001008DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-12
00884883002890DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-12
00817302021851CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT KIT Product No. DT421CAROLINA LIQUID CHEMISTRIES CORPORATIONDMT2016-09-01
15099590223335SynchronBeckman Coulter, Inc.DMT2016-08-24
10758750004270VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DMT2016-08-23
00380740005559ARCHITECTABBOTT LABORATORIESDMT2016-06-06