PROFILE®-V MEDTOXScan®

FDA UDI

Class II (US FDA UDI)

by Medtox Diagnostics, Inc.

Identity

Trade Name: PROFILE®-V MEDTOXScan® FDA UDI
Generic Name: Multiplex analyser IVD, laboratory FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 604018 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00690286000018 FDA UDI
510(k) Number: K080635 FDA UDI
K091454 FDA UDI
FDA Product Code: LDJ FDA UDI
JXN FDA UDI
DIS FDA UDI
DJR FDA UDI
LFI FDA UDI
JXM FDA UDI
DKZ FDA UDI
DJG FDA UDI
DJC FDA UDI
DIO FDA UDI
LCM FDA UDI
GMDN Term: Multiplex analyser IVD, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3870 FDA UDI
862.3700 FDA UDI
862.3150 FDA UDI
862.3620 FDA UDI
862.3910 FDA UDI
862.3170 FDA UDI
862.3100 FDA UDI
862.3650 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiplex analyser IVD, laboratory

PROFILE®-V MEDTOXScan® by Medtox Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K091454 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtox Diagnostics, Inc.

Sources (1)

FDA UDI f975057b-7332-4aa6-9b15-fb4b73c4502d 36 fields · synced Jun 8, 2026