PROFILE-II ER®

GUDID 00690286000315

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.

MEDTOX DIAGNOSTICS, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00690286000315
NIH Device Record Key8747b0a8-0785-4259-b614-8f6a274ebcac
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROFILE-II ER®
Version Model Number601674
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
GS100690286000315 [Primary]
GS110690286000312 [Package]
Package: kit box [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXNEnzyme Immunoassay, Propoxyphene

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-II ER®]

00690286000315A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC),
10690286000299A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC),
10690286000282A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC),
10690286000275A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC),
00690286000780A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC),

Trademark Results [PROFILE-II ER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROFILE-II ER
PROFILE-II ER
78231820 2815137 Live/Registered
LABORATORY CORPORATION OF AMERICA HOLDINGS
2003-03-31

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