FDA.reportPublic FDA data

GenaCheck Alcohol Rapid Self-Test Kit

Primary DI
10810143620044
Brand
GenaCheck Alcohol Rapid Self-Test Kit
Company
Genabio Diagnostics Inc.
Model
RA9-E01905
Published
2023-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DMJTest Reagents For Ethyl Alcohol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DMJTest Reagents For Ethyl AlcoholClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143620047PrimaryGS10
10810143620044Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143620047008101436200478101436200470810143620047
1081014362004410810143620044

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118586095
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143620221GenaCheck® Early Result Pregnancy TestN/A2025-02-26
00810143620115GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E197002025-01-13
00810143620139GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E198002025-01-13
00810143620146GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E199002025-01-13
00810143620153GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E201002025-01-13
00860008954800GenaCheck™ Fentanyl Urine Home-Use Test CassetteRA9-E02525RA9-E025012024-06-14
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TN/A2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TN/A2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TN/A2026-01-21
00810143620344GenaCheck® COVID-19/Flu A&B Rapid Self-TestRA9-E024022025-05-19
00810143620368GenaCheck® COVID-19/Flu A&B Rapid Self-TestRA9-E024042025-05-19
00810143620214GenaCheck® FSH At-Home Menopause TestN/A2025-02-26
00810143620184Genabio COVID-19 Rapid Self-Test KitN/A2025-01-13
00810143620191GenaCheck®LH At-Home Ovulation Prediction TestN/A2025-01-13
00810143620207GenaCheck®PdG At-Home Ovulation Confirmation TestN/A2025-01-13
00860008954817GenaCheck®Fentanyl Urine Test CassetteN/ARA9-E025252025-01-13
00810143620009GenaCheck Rapid Self-Test Kit For Urinary Tract InfectionsRA9-E018022023-10-06
00810143620047GenaCheck Alcohol Rapid Self-Test KitRA9-E019052023-10-06
00810143620054GenaCheck 5-Drug Rapid Self-Test KitRA9-E021052023-10-06
00810143620061GenaCheck 12-Drug Rapid Self-Test KitRA9-E019022023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810143451603MD DrugScreenMedical Disposables CorpDMJ2025-10-10
00810143620047GenaCheck Alcohol Rapid Self-Test KitGenabio Diagnostics Inc.DMJ2023-10-06
00850041101750Onsite DrugScreenMedical Disposables CorpDMJ2023-04-24
D82852000580Zendura Clear Retainer - LowerFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCDMJ2022-12-12
D82852000590Dual-Laminate Essix LowerFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCDMJ2022-12-12
06970429841420co-innovationCo-Innovation Biotech Co., LtdDMJ2018-10-08
00895330002752Healgen (Private Label) EtG Urine Dip *300ngCONFIRM BIOSCIENCES, INC.DMJ2016-09-06