Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1050155

FEI Number

1050155

Entity Name

MEDTOX DIAGNOSTICS, INC.

City/State/Country

BURLINGTON, NC, US

Establishment Address

1238 Anthony Rd, 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

K020787

PMA Number

N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	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
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
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2008-02-12
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
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2025-12-05
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
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
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2026-05-18
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
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
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2008-02-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2008-02-19
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
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2026-03-04
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
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2025-12-05
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
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2018-12-14
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
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2008-02-12

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
3004175381	MEDTOX DIAGNOSTICS, INC.	BURLINGTON, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112395	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST	2011-09-09
K142609	Guangzhou Wondfo Biotech Co., Ltd.	CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine	2014-12-18
K131232	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)	2013-05-31
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2013	Alere San Diego, Inc.	2	Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
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
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

Similar Registrations

Registration Number	Establishment Name	Location
3004987297	UCP BIOSCIENCES, INC.	Milpitas, CA, US
3008852306	Chemtron Biotech, Inc.	San Diego, CA, US
3008416529	MICRO DISTRIBUTING II, LTD.	Belton, TX, US
3005345870	W.H.P.M. Bioresearch & Technology Co., Ltd.	BEIJING, CN
3011559327	Prometheus Bio Inc.	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1050155. Last updated year: 2026. Please use registration number 1050155 when referencing this establishment in official correspondence.