Data / Medical devices / United States / Medtox Diagnostics, Inc.

Medtox Diagnostics, Inc.: FDA-registered device maker in Burlington, NC, United States, 22 510(k) clearances

Name: Medtox Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medtox Diagnostics, Inc. is registered with the FDA (registration 1050155) in Burlington, NC, United States. It lists 18 device types. The FDA files 22 510(k) clearances under its listings, the newest dated January 29, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1050155
Address: 1238 Anthony Rd, Burlington, NC, United States, 27215
Owner or operator: MEDTOX DIAGNOSTICS, INC. (1050155)
Roles: Manufacturer, Manufacturer for export, Specification developer
First device listed: September 29, 2003
Registered through: 2026
Brand names listed: EZ-SCREEN, Labcorp, Labcorp Comfort Draw, MEDTOX, MEDTOX OXYCODONE, MEDTOXScan, P-V MEDTOXScan, PROFILE-II and more

Devices it lists

Device	Product code	Class	Role	Source
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Manufacturer	accessdata.fda.gov
Drug Mixture Control Materials	DIF	1	Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Manufacturer	accessdata.fda.gov
High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	LFI	2	Manufacturer	accessdata.fda.gov
Micro Pipette	JRC	1	Specification developer	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Specification developer	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Manufacturer	accessdata.fda.gov
Reagents, Test, Tetrahydrocannabinol	DKE	2	Manufacturer	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 29, 2026	K252684	Labcorp Fentanyl Urine Visual Test	DJG	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
February 23, 2016	K153474	Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series	DIF	Substantially Equivalent	Biochemical Diagnostics, Inc.	accessdata.fda.gov
October 18, 2010	K100951	MEDTOX BUPRENORPHINE TEST	DJG	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
April 5, 2010	K100023	PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM	DJG	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
July 24, 2009	K091454	PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM	DJG	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
February 13, 2009	K080635	MEDTOXSCAN	DKZ	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
May 12, 2006	K060351	MEDTOX OXYCODONE	DJG	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
October 25, 2005	K050394	SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS	DKZ	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
July 14, 2003	K031032	VERDICT II, PROFILE II	DJG	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
July 30, 2002	K022141	VERDICT-II	DJC	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
May 2, 2002	K020787	VERDICT-II PROPOXYPHENE	JXN	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
June 8, 2001	K011545	VERDICT -II TCA, VERDICT-II MTD	LFG	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
June 1, 2001	K010226	VERDICT -II METHAMPHETAMINE	DJC	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
April 13, 2001	K010959	VERDICT -II BAR; VERDICT -II BZO	DIS	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
April 5, 2001	K010564	VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO	DKZ	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
April 5, 2001	K010561	VERDICT -II BAR/BZO	DIS	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
February 14, 2001	K010138	PROFILE II ER	LDJ	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
January 17, 2001	K002331	PROFILE-ER	DIS	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
December 22, 2000	K003687	VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC	DKE	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
September 28, 2000	K002776	MODIFICATION TO PROFILE -II	LCM	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
December 16, 1999	K992111	VERDICT -II OPIATES 2000	DJG	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov
July 29, 1998	K982211	PROFILE-II MODEL 600582	DKE	Substantially Equivalent	Medtox Diagnostics, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 5, 2013	64800	Class II	Terminated	PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine	Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.	accessdata.fda.gov
February 8, 2008	47501	Not yet classified	Terminated	MEDTOXscan Reader	Reader was marketed without a 510(k).	accessdata.fda.gov

Compare with other makers

Updated January 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.