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Verdict®-Ii

FDA UDI

Class II (US FDA UDI)

by Medtox Diagnostics, Inc.

Identity

Trade Name
VERDICT®-II FDA UDI
Generic Name
Methamphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
Device Name
A qualitative one-step immunochromatographic test for the detection of Methamphetamine, MDMA and/or metabolites in human urine. FDA UDI
Model / Reference
601598 FDA UDI
Description
A qualitative one-step immunochromatographic test for the detection of Methamphetamine, MDMA and/or metabolites in human urine. FDA UDI

Identifiers

Primary DI / UDI-DI
00690286000162 FDA UDI
510(k) Number
K010226 FDA UDI
FDA Product Code
DJC FDA UDI
GMDN Term
Methamphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3610 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Verdict®-Ii by Medtox Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K010226 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtox Diagnostics, Inc.

Sources (1)

  • FDA UDI 3f71ab1a-2943-407b-be46-f4eca9a175d4 37 fields · synced Jun 8, 2026