PROFILE-II ER®

Basic Information

• Brand Name: PROFILE-II ER®
• Primary DI: 00690286000780
• Version / Model: 601684
• Company Name: MEDTOX DIAGNOSTICS, INC.
• Labeler DUNS: 137417965
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-01
• Public Version: 1
• Public Version Date: 2023-06-09
• Public Version Status: New
• Public Device Record Key: 513dd159-836b-430c-b017-fef9ff81e01b

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	862.3910	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	862.3870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690286000780	GS1
Package	10690286000787	GS1	kit box	25	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K002331	000
K010226	000
K060351	000
K982211	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius