PROFILE®-V MEDTOXScan®

GUDID 00690286000049

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, Propoxyphene, and Buprenorphine drugs and/or metabolites in human urine.

MEDTOX DIAGNOSTICS, INC.

Multiplex analyser IVD, laboratory, semi-automated
Primary Device ID00690286000049
NIH Device Record Key60777068-a1c5-4c4f-96ec-41d1a9cf534e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROFILE®-V MEDTOXScan®
Version Model Number604022
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com
Phone877-643-5703
Emailtechservices@medtoxdiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100690286000049 [Primary]
GS110690286000046 [Package]
Package: Kit Box [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

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 Date2016-09-16

On-Brand Devices [PROFILE®-V MEDTOXScan®]

00690286000575Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V ME
00690286000568Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V ME
10690286000053A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
00690286000049A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
10690286000039A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
10690286000022A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
00690286000018A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
00690286000643Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V ME
00690286000636Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V ME
10690286000763A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
10690286000756A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),

Trademark Results [PROFILE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROFILE
PROFILE
98648871 not registered Live/Pending
Fidelity Information Services, LLC
2024-07-15
PROFILE
PROFILE
98602677 not registered Live/Pending
360 Electrical, LLC
2024-06-14
PROFILE
PROFILE
98506309 not registered Live/Pending
Thomas, John
2024-04-18
PROFILE
PROFILE
98428022 not registered Live/Pending
Oregon Global Distribution Inc.
2024-02-29
PROFILE
PROFILE
97631240 not registered Live/Pending
Musculoskeletal Transplant Foundation
2022-10-13
PROFILE
PROFILE
97328981 not registered Live/Pending
Profile Plan, LLC
2022-03-24
PROFILE
PROFILE
97251268 not registered Live/Pending
HAIER US APPLIANCE SOLUTIONS, INC.
2022-02-03
PROFILE
PROFILE
90906611 not registered Live/Pending
Sanford, L.P.
2021-08-27
PROFILE
PROFILE
90154383 not registered Live/Pending
Sanford Frontiers
2020-09-02
PROFILE
PROFILE
88910425 not registered Live/Pending
Berry Global, Inc.
2020-05-11
PROFILE
PROFILE
88348273 not registered Live/Pending
Wilson Sporting Goods Co.
2019-03-20
PROFILE
PROFILE
88348268 not registered Live/Pending
Wilson Sporting Goods Co.
2019-03-20
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