Medtox®

FDA UDI

Class I (US FDA UDI)

by Medtox Diagnostics, Inc.

Identity

Trade Name: MEDTOX® FDA UDI
Generic Name: Multiple drugs of abuse IVD, control FDA UDI
Device Name: Negative toxicology urine control used to monitor and validate the performance of PROFILE®-V MEDTOXScan® and MEDTOX® drugs of abuse test devices. FDA UDI
Model / Reference: 101183 FDA UDI
Description: Negative toxicology urine control used to monitor and validate the performance of PROFILE®-V MEDTOXScan® and MEDTOX® drugs of abuse test devices. FDA UDI

Identifiers

Primary DI / UDI-DI: 00690286000551 FDA UDI
FDA Product Code: DIF FDA UDI
GMDN Term: Multiple drugs of abuse IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.3280 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple drugs of abuse IVD, control

Medtox® by Medtox Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Medtox Diagnostics, Inc.

Sources (1)

FDA UDI 5b4a58ad-6aba-44aa-8a0b-3f66482a6a31 35 fields · synced Jun 8, 2026