PROFILE®-V MEDTOXScan®

Basic Information

• Brand Name: PROFILE®-V MEDTOXScan®
• Primary DI: 00690286000049
• Version / Model: 604022
• Company Name: MEDTOX DIAGNOSTICS, INC.
• Labeler DUNS: 137417965
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 6
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 60777068-a1c5-4c4f-96ec-41d1a9cf534e

Device Description

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.

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
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	862.3700	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	862.3910	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
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
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56727	Multiplex analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software.	No	Active
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	00690286000049	GS1
Package	10690286000046	GS1	Kit Box	25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080635	000
K091454	000
K100023	000

Storage Conditions

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