FDA.reportPublic FDA data

GenaCheck®Fentanyl Urine Test Cassette

Primary DI
00860008954817
Brand
GenaCheck®Fentanyl Urine Test Cassette
Company
Genabio Diagnostics Inc.
Model
N/A
Catalog number
RA9-E02525
Published
2025-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008954817PrimaryGS10
86000895481700Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008954817008600089548178600089548170860008954817
8600089548170086000895481700

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118586095
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

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
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
10810143620006GenaCheck Rapid Self-Test Kit For Urinary Tract InfectionsRA9-E018022023-10-06