At Home Single Panel COC + Timer

GUDID 00674033090736

Single Panel Cocaine urine drug test device with Timer

PHAMATECH, INCORPORATED

Cocaine/cocaine metabolite IVD, kit, immunochromatographic test (ICT), rapid Cocaine/cocaine metabolite IVD, kit, immunochromatographic test (ICT), rapid Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Primary Device ID00674033090736
NIH Device Record Keyaf301f00-3b28-44d2-87e0-9096dc4d3a41
Commercial Distribution StatusIn Commercial Distribution
Brand NameAt Home Single Panel COC + Timer
Version Model Number9073T
Company DUNS947803078
Company NamePHAMATECH, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone877-466-3837
Emailathomedrugtest@phamatech.com
Phone877-466-3837
Emailathomedrugtest@phamatech.com
Phone877-466-3837
Emailathomedrugtest@phamatech.com
Phone877-466-3837
Emailathomedrugtest@phamatech.com
Phone877-466-3837
Emailathomedrugtest@phamatech.com
Phone877-466-3837
Emailathomedrugtest@phamatech.com
Phone877-466-3837
Emailathomedrugtest@phamatech.com
Phone877-466-3837
Emailathomedrugtest@phamatech.com
Phone877-466-3837
Emailathomedrugtest@phamatech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100674033090736 [Primary]

FDA Product Code

DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-02

Devices Manufactured by PHAMATECH, INCORPORATED

00674033090682 - At Home Drug Test for Methamphetamine2018-03-29 Urine based drug testing device for Methamphetamine
00674033090736 - At Home Single Panel COC + Timer2018-03-29Single Panel Cocaine urine drug test device with Timer
00674033090736 - At Home Single Panel COC + Timer2018-03-29 Single Panel Cocaine urine drug test device with Timer
00674033090781 - At Home Drug Test for Marijuana2018-03-29 Urine based drug of abuse test for THC
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