AccessGUDID - DEVICE: PROFILE®-V MEDTOXScan® (00690286000018)

GUDID

Device Identifier (DI) Information

Brand Name: PROFILE®-V MEDTOXScan®
Version or Model: 604018
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTOX DIAGNOSTICS, INC.

Primary DI Number: 00690286000018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137417965 *Terms of Use

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, and Propoxyphene drugs and/or metabolites in human urine.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDJ	Enzyme Immunoassay, Cannabinoids
JXN	Enzyme Immunoassay, Propoxyphene
DIS	Enzyme Immunoassay, Barbiturate
DJR	Enzyme Immunoassay, Methadone
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
JXM	Enzyme Immunoassay, Benzodiazepine
DKZ	Enzyme Immunoassay, Amphetamine
DJG	Enzyme Immunoassay, Opiates
DJC	Thin Layer Chromatography, Methamphetamine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LCM	Enzyme Immunoassay, Phencyclidine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080635	000
K091454	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f975057b-7332-4aa6-9b15-fb4b73c4502d
Public Version Date: September 16, 2022
Public Version Number: 6
DI Record Publish Date: September 16, 2016