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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
Benzodiazepine group IVD, kit, rapid ICT, clinical FDA UDI
Device Name
A qualitative one-step immunochromatographic test for the detection of Benzodiazepines and/or metabolites in human urine. FDA UDI
Model / Reference
601624 FDA UDI
Description
A qualitative one-step immunochromatographic test for the detection of Benzodiazepines and/or metabolites in human urine. FDA UDI

Identifiers

Primary DI / UDI-DI
00690286000186 FDA UDI
510(k) Number
K002331 FDA UDI
K010959 FDA UDI
FDA Product Code
JXM FDA UDI
GMDN Term
Benzodiazepine group IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3170 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

K002331 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 47a212b6-f3fe-45a3-9a1e-373ff6266deb 37 fields · synced Jun 8, 2026