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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 1 of 3

Device	Model / Reference	Registries	Class	Status
Ez-Screen® Cup	605105	FDA UDI	Class II	Unknown
Men's Rapid Fertility Test	TRK-0-1 Rev 4	FDA UDI	Class II	Active
Sure-Screen®	600686	FDA UDI	Class II	Unknown
Ez-Screen® Cup	605103	FDA UDI	Class II	Active
Profile-Ii Er®	601674	FDA UDI	Class II	Active
Ez-Screen® Cup	605102	FDA UDI	Class II	Active
Verdict®-Ii	601629	FDA UDI	Class II	Active
PROFILE®-V MEDTOXScan®	102367	FDA UDI	Class I	Active
Medtox®	102368	FDA UDI	Class I	Active
Sure-Screen®	600715	FDA UDI	Class II	Unknown
PROFILE®-V MEDTOXScan®	604022	FDA UDI	Class II	Active
Trak	TZZ-0-1C	FDA UDI	Class II	Unknown
PROFILE®-V MEDTOXScan®	604020	FDA UDI	Class II	Active
PROFILE®-V MEDTOXScan®	102435	FDA UDI	Class I	Active
Verdict®-Ii	601643	FDA UDI	Class II	Unknown
Verdict®-Ii	601622	FDA UDI	Class II	Active
Sure-Screen®	600680	FDA UDI	Class II	Unknown
Trak	TTK-0-1 Rev 2	FDA UDI	Class II	Unknown
Ez-Screen® Cup	605201	FDA UDI	Class II	Active
Verdict®-Ii	601594	FDA UDI	Class II	Unknown
Ez-Screen® Cup	605212	FDA UDI	Class II	Active
Profile®-Iia	601677	FDA UDI	Class II	Active
Ez-Screen® Cup	605104	FDA UDI	Class II	Active
Medtox®	102366	FDA UDI	Class I	Active
PROFILE®-V MEDTOXScan®	604018	FDA UDI	Class II	Active
PROFILE®-V MEDTOXScan®	604031	FDA UDI	Class II	Active
PROFILE®-V MEDTOXScan®	102365	FDA UDI	Class I	Active
Ez-Screen® Cup	605106	FDA UDI	Class II	Unknown
Verdict®-Ii	601598	FDA UDI	Class II	Unknown
Torq	ZZP-MR-RS Rev 0	FDA UDI	Class I	Active
Verdict®-Ii	601624	FDA UDI	Class II	Unknown
Medtox®	101183	FDA UDI	Class I	Active
Profile®-Iia	601683	FDA UDI	Class II	Active
MEDTOXScan® QC Test Devices	833075	FDA UDI	Class I	Active
Ez-Screen® Cup	605204	FDA UDI	Class II	Active
Sure-Screen®	600723	FDA UDI	Class II	Unknown
Verdict®-Ii	601639	FDA UDI	Class II	Unknown
PROFILE®-V MEDTOXScan®	604019	FDA UDI	Class II	Active
MEDTOXScan® Cleaning Cassette	833076	FDA UDI	Class I	Active
Medtox® Oxycodone	601675	FDA UDI	Class II	Active
Verdict®-Ii	601584	FDA UDI	Class II	Unknown
Profile®-Iia	601599	FDA UDI	Class II	Active
MEDTOXScan®	833077	FDA UDI	Class I	Active
Profile-Ii Er®	601672	FDA UDI	Class II	Active
PROFILE®-V MEDTOXScan®	604032	FDA UDI	U	Active
Torq	ZZP-MR-1 Rev 0	FDA UDI	Class I	Active
Profile-Ii Er®	601684	FDA UDI	Class II	Active
Verdict®-Ii	601587	FDA UDI	Class II	Unknown
Ez-Screen® Cup	605101	FDA UDI	Class II	Active
TrueSpin	S001	FDA UDI	Class I	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).