PROFILE®-IIA

GUDID 00690286000346

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Phencyclidine drugs and/or their metabolites in human urine.

MEDTOX DIAGNOSTICS, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00690286000346
NIH Device Record Keyca96cb10-f260-4ca0-b8be-95d79f55ddfc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROFILE®-IIA
Version Model Number601599
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100690286000346 [Primary]
GS110690286000343 [Package]
Package: kit box [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

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®-IIA]

00690286000360A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC),
00690286000353A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC),
00690286000346A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC),
00690286000308A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC),
10690286000770A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC),

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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