Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004175381

FEI Number

3004175381

Entity Name

MEDTOX DIAGNOSTICS, INC.

City/State/Country

BURLINGTON, NC, US

Establishment Address

1640 NOVA LANE, BURLINGTON, NC 27215, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDTOX DIAGNOSTICS, INC. (Owner Number: 1050155)

Owner / Operator Contact Address

1238 ANTHONY RD., --, Burlington, NC 27215, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080635

PMA Number

N/A

All Registered Proprietary Names

PROFILE-IIA PROFILE-II EZ-SCREEN PROFILE-II VERDICT-II MEDTOX OXYCODONE PROFILE-II ER PROFILE-IIA PROFILE-II VERDICT-II EZ-SCREEN VERDICT-II PROFILE-II PROFILE-IIA VERDICT-II PROFILE-II VERDICT-II PROFILE-II PROFILE-II ER EZ-SCREEN PROFILE-IIA PROFILE-IIA PROFILE-II EZ-SCREEN Labcorp Comfort Draw PROFILE-V MEDTOXScan PROFILE-V MEDTOXScan P-V MEDTOXScan MEDTOX EZ-SCREEN VERDICT-II VERDICT-II PROFILE-II VERDICT-II PROFILE-II PROFILE-II PROFILE-II ER MEDTOX PROFILE-V P-V MEDTOXScan PROFILE-V MEDTOXScan MEDTOXScan PROFILE-V MEDTOXScan EZ-SCREEN VERDICT-II EZ-SCREEN PROFILE-II PROFILE-II ER PROFILE-IIA PROFILE-II PROFILE-II ER VERDICT-II EZ-SCREEN PROFILE-IIA MEDTOX PROFILE-V MEDTOXScan P-V MEDTOXScan MEDTOXScan PROFILE-V

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-02-12
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2011-01-24
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2011-01-24
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2011-01-24
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2011-01-24
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2003-09-29
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2008-02-19
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2008-02-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2008-12-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-12-15
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2008-12-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-12-15
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2008-12-15
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2008-12-15
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-12-15
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2008-02-12
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2008-02-12
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2008-02-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2008-02-12
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-02-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-02-12
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2008-02-12
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-02-12
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2025-12-05
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2026-05-18
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2009-12-14
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2009-12-14
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2009-12-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2010-12-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-02-12
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-02-12
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2008-02-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2008-02-12
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-02-12
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2008-02-12
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2008-02-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-02-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2008-02-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-02-19
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2008-02-19
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2008-02-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2008-02-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-02-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2008-02-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2008-02-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2010-12-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2018-12-14
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2008-02-12
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2008-02-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2008-02-12
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2008-02-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-02-12
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-02-12
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2008-02-12
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-02-12
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-02-19
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2008-02-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-02-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-02-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2008-02-19
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2008-02-12
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2008-02-12
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2008-02-12
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2008-02-12
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2009-03-09
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2009-03-09
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2009-03-09
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2009-03-09
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2009-03-09
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2009-03-09
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2009-03-09
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2009-03-09
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2009-03-09
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2009-03-09

Official Correspondent

ELIZABETH BROCK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDTOX DIAGNOSTICS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011260354	MEDTOX Diagnostics, Inc.	Pleasanton, CA, US
1050155	MEDTOX DIAGNOSTICS, INC.	BURLINGTON, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153050	Co-Innovation Biotech Co., Ltd.	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	2016-04-26
K151478	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo CR3 Keyless Split Sample Cup	2015-07-01
K150179	Guangzhou Wondfo Biotech Co., Ltd.	CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids	2015-02-25
K112310	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHADONE URINE TEST,OPIATE TEST	2011-09-08
K093175	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES	2010-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-2787-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2788-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2789-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004175381. Last updated year: 2026. Please use registration number 3004175381 when referencing this establishment in official correspondence.