FDA.reportPublic FDA data

DTX®

Primary DI
10858917006007
Brand
DTX®
Company
ONE STEP DETEX ASSOCIATES
Model
DAM-114
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858917006007PrimaryGS10
00858917006000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085891700600710858917006007
00858917006000008589170060008589170060000858917006000

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA 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. This test is commonly 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

Contacts#

Phone, Email table
PhoneEmail
(888)822-7120xx@xx.xx

Regulatory Flags#

DUNS number
044096902
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10858917006014DTX®DBZ-1142016-09-24
10858917006021DTX®DCO-1142016-09-24
10858917006038DTX®DMA-1142016-09-24
10858917006045DTX®DOA-11042016-09-24
10858917006052DTX®DOA-1242016-09-24
10858917006069DTX®DBA-1142016-09-24
10858917006076DTX®DMD-1142016-09-24
10858917006083DTX®DMT-1142016-09-24
10858917006106DTX®DOP-1142016-09-24
10858917006113DTX®DPC-1142016-09-24
10858917006120DTX®DTH-1142016-09-24
10858917006144DTX®DOX-1142016-09-24
10858917006151DTX®DOA-11452016-09-24
10858917006175DTX® DOA-21652016-09-24
10858917006199DTX®DOA-1342016-09-24
10858917006205DTX®DOA-1442016-09-24
10858917006212DTX®DOA-1542016-09-24
10858917006243DTX®DOA-9542016-09-24
10858917006250DTX®DOA-1842016-09-24
10858917006267DTX® DBU-1142016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDKZ2023-04-28
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2021-06-24
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDKZ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2019-03-11
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-12-05
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-10-29
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-06-20
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncDKZ2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncDKZ2018-05-21
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-04-19
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-03-23
10694644500377RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-03-14