DTX®

GUDID 10858917006212

ONE STEP DETEX ASSOCIATES

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID10858917006212
NIH Device Record Key0b593084-0586-4968-9213-29be5c9cd92b
Commercial Distribution Discontinuation2019-02-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDTX®
Version Model NumberDOA-154
Company DUNS044096902
Company NameONE STEP DETEX ASSOCIATES
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx
Phone(888)822-7120
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100858917006215 [Unit of Use]
GS110858917006212 [Primary]

FDA Product Code

LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-05-24
Device Publish Date2016-09-24

On-Brand Devices [DTX®]

10858917006335DOA-264
10858917006328DOA-144-851
10858917006311DOA-1257
10858917006304DOA-1127-061
10858917006298DOA-197-141
10858917006281DOA-2167
10858917006274DOA-164-1201
10858917006267DBU-114
10858917006250DOA-184
10858917006243DOA-954
10858917006212DOA-154
10858917006205DOA-144
10858917006199DOA-134
10858917006175DOA-2165
10858917006151DOA-1145
10858917006144DOX-114
10858917006120DTH-114
10858917006113DPC-114
10858917006106DOP-114
10858917006083DMT-114
10858917006076DMD-114
10858917006069DBA-114
10858917006052DOA-124
10858917006045DOA-1104
10858917006038DMA-114
10858917006021DCO-114
10858917006014DBZ-114
10858917006007DAM-114

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