MEDTOXScan® Reader

GUDID 00690286000063

An instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Devices, which are one-step immunochromatographic tests for the rapid, qualitative detection of one or more drugs in human urine.

MEDTOX DIAGNOSTICS, INC.

Multiplex analyser IVD, laboratory, semi-automated
Primary Device ID00690286000063
NIH Device Record Key7ca1f86b-daa8-400c-81c3-56e2b401c8b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDTOXScan® Reader
Version Model Number833073
Company DUNS137417965
Company NameMEDTOX DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100690286000063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by MEDTOX DIAGNOSTICS, INC.

10690286000756 - PROFILE®-V MEDTOXScan®2023-08-09 A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamp
10690286000763 - PROFILE®-V MEDTOXScan®2023-08-09 A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamp
10690286000770 - PROFILE®-IIA2023-06-09 A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamine, Cocaine,
00690286000780 - PROFILE-II ER®2023-06-09 A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine,
00860001286533 - Men's Rapid Fertility Test2022-08-03 Men's Rapid Fertility Test, QC Kit
00862105000398 - Trak2022-07-13 Trak Male Fertility Testing System, 1-Test Kit
00862105000305 - Men's Rapid Fertility Test2022-06-21 Men's Rapid Fertility Test, 2-Test Kit
00862105000312 - Men's Rapid Fertility Test2022-06-21 Men's Rapid Fertility Test, 2-Test Refill Kit

Trademark Results [MEDTOXScan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEDTOXSCAN
MEDTOXSCAN
78599342 3113146 Live/Registered
LABORATORY CORPORATION OF AMERICA HOLDINGS
2005-03-31
MEDTOXSCAN
MEDTOXSCAN
78599338 3122100 Live/Registered
LABORATORY CORPORATION OF AMERICA HOLDINGS
2005-03-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.