FDA.reportPublic FDA data

Detectabuse

Primary DI
00810042680586
Brand
Detectabuse
Company
BIOCHEMICAL DIAGNOSTICS INC
Model
18007536
Catalog number
18007536
Device description
Urine Alcohol kitbox, 2x4mL
Published
2020-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DIFDrug Mixture Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810042680586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042680586008100426805868100426805860810042680586

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028007698
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042684416DETECTABUSE18008790180087902025-06-13
00810042684423DETECTABUSE18008791180087912025-06-13
00810042684430DETECTABUSE18008792180087922025-06-13
00810042684447DETECTABUSE18008793180087932025-06-13
00810042684119DETECTABUSE18008255180082552024-06-12
00810042684126DETECTABUSE18008256180082562024-06-12
00810042684133DETECTABUSE18008288180082882024-06-12
00810042684140DETECTABUSE18008289180082892024-06-12
00810042684355DETECTABUSE7020407020402025-03-19
00810042684362CliawaivedMultitox-PC-25GMultitox-PC-25G2025-03-17
00810042683822DETECTABUSE26797267972025-02-20
00810042684331DETECTABUSE18008622180086222024-12-09
00810042684348DETECTABUSE18008623180086232024-12-09
00810042684324CliawaivedMultitox-PC-25FMultitox-PC-25F2024-11-21
00810042684263DETECTABUSE19481310194813102024-10-31
00810042684270DETECTABUSE19481320194813202024-10-31
00810042684287DETECTABUSE19481340194813402024-10-31
00810042684294DETECTABUSE19481350194813502024-10-31
00810042684300DETECTABUSE19481360194813602024-10-31
00810042684317DETECTABUSE19481370194813702024-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690286000742MEDTOX®MEDTOX DIAGNOSTICS, INC.DIF2026-03-31
00810042684416DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684423DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684430DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684447DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684355DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-19
00810042684362CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-17
00810042683822DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-02-20
00810042684331DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684348DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684324CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2024-11-21
00810042684263DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684270DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684287DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684294DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684300DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684317DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684249DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-02
00810042684256DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-02
00810042684232iScreenBIOCHEMICAL DIAGNOSTICS INCDIF2024-07-22
00810042683976DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042683983DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042683990DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684003DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684010DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684027DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684034DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684041DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684058DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684065DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12