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MEDTOX DIAGNOSTICS, INC.

Last updated September 17, 2026

Information

Country: US
Address: 1238 Anthony Rd, BURLINGTON, NC, 27215
Website: medtoxdiagnostics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 877-643-5703
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1050155
DUNS Number: 137417965

Catalogue (103)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Trak	TRK-0-1 Rev 3	FDA UDI	Class II	Unknown
Torq	ZZP-MD2-1 Rev 0	FDA UDI	Class I	Active
Verdict®-Ii	601585	FDA UDI	Class II	Unknown
Ez-Screen® Cup	605202	FDA UDI	Class II	Active
Trak	TTK-0-3 Rev 3	FDA UDI	Class II	Unknown
Medtox®	102350	FDA UDI	Class I	Active
Ez-Screen® Cup	605205	FDA UDI	Class II	Active
Verdict®-Ii	601651	FDA UDI	Class II	Unknown
Ez-Screen® Cup	605100	FDA UDI	Class II	Active
Men's Rapid Fertility Test	TTK-0-3 Rev 4	FDA UDI	Class II	Active
Verdict®-Ii	601682	FDA UDI	Class II	Active
PROFILE®-V MEDTOXScan®	604028	FDA UDI	Class II	Active
Ez-Screen® Cup	605211	FDA UDI	Class II	Active
PROFILE®-V MEDTOXScan®	102436	FDA UDI	Class I	Active
Ez-Screen® Cup	605203	FDA UDI	Class II	Active
Verdict®-Ii	601593	FDA UDI	Class II	Unknown
Ez-Screen® Cup	605200	FDA UDI	Class II	Active
Verdict®-Ii	601638	FDA UDI	Class II	Unknown
Verdict®-Ii	601640	FDA UDI	Class II	Unknown
Medtox®	102352	FDA UDI	Class I	Active
Verdict®-Ii	601630	FDA UDI	Class II	Unknown
Medtox®	102351	FDA UDI	Class I	Active
Profile®-Ii	601607	FDA UDI	Class II	Active
Profile-Ii Er®	601636	FDA UDI	Class II	Active
Profile-Ii Er®	601591	FDA UDI	Class II	Active
Verdict®-Ii	601645	FDA UDI	Class II	Unknown
Verdict®-Ii	601586	FDA UDI	Class II	Unknown
MEDTOXScan® Reader	833073	FDA UDI	Class I	Active
Men's Rapid Fertility Test	TQK-0-1	FDA UDI	Class II	Active
Profile®-Iia	601660	FDA UDI	Class II	Active
Profile®-Iia	601673	FDA UDI	Class II	Active
Profile-V Medtoxscan Drugs Of Abuse Test System	K091454	FDA 510(k)	Class II	Active
Verdict -ii Tca, Verdict-Ii Mtd	K011545	FDA 510(k)	Class II	Active
Verdict Ii Thc/Coc/Opi/Amp, Verdictii Thc/Coc/Opi, Verdict Ii Thc/Coc/Amp, Verdict Ii Thc/Coc/Pcp, Verdict Ii Thc/Coc	K003687	FDA 510(k)	Class II	Active
Verdict -ii Bar/Bzo	K010561	FDA 510(k)	Class II	Active
Profile Ii Er	K010138	FDA 510(k)	Class II	Active
Profile-Er	K002331	FDA 510(k)	Class II	Active
Profile -er	K033334	FDA 510(k)	Class II	Active
Medtoxscan	K080635	FDA 510(k)	Class II	Active
Profile-V Medtoxscan Drugs Of Abuse Test System And 12 Drugs Test System	K100023	FDA 510(k)	Class II	Active
Verdict -ii Bar; Verdict -ii Bzo	K010959	FDA 510(k)	Class II	Active
Labcorp Fentanyl Urine Visual Test	K252684	FDA 510(k)	Class II	Active
Medtox Oxycodone	K060351	FDA 510(k)	Class II	Active
Verdict -ii Thc/Coc/Opi/Amp/Pcp/Bar/Bzo & Thc/Coc/Bar/Bzo; Profile -ii 7 Thc/Coc/Opi/Amp/Pcp/Bar/Bzo	K010564	FDA 510(k)	Class II	Active
Verdict -ii Methamphetamine	K010226	FDA 510(k)	Class II	Active
Verdict-Ii Propoxyphene	K020787	FDA 510(k)	Class II	Active
Medtox Buprenorphine Test	K100951	FDA 510(k)	Class II	Active
Verdict Ii, Profile Ii	K031032	FDA 510(k)	Class II	Active
Verdict -ii Opiates 2000	K992111	FDA 510(k)	Class II	Active
Verdict-Ii	K022141	FDA 510(k)	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 5, 2013	Z-1329-2013	—	terminated	Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.
Feb 8, 2008	Z-2202-2008	—	terminated	Reader was marketed without a 510(k).