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MEDTOXScan®

FDA UDI

Class I (US FDA UDI)

by Medtox Diagnostics, Inc.

Identity

Trade Name
MEDTOXScan® FDA UDI
Generic Name
Mechanical pipette FDA UDI
Device Name
A micro pipette designed to dispense an accurate volume of sample for the PROFILE®-V MEDTOXScan® Test Devices. FDA UDI
Model / Reference
833077 FDA UDI
Description
A micro pipette designed to dispense an accurate volume of sample for the PROFILE®-V MEDTOXScan® Test Devices. FDA UDI

Identifiers

Primary DI / UDI-DI
00690286000094 FDA UDI
510(k) Number
K080635 FDA UDI
K091454 FDA UDI
K100023 FDA UDI
FDA Product Code
JRC FDA UDI
GMDN Term
Mechanical pipette FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mechanical pipette

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

Similar devices

Also classified as Mechanical pipette.

Cleared under the same submission

K080635 also covers:

K091454 also covers:

K100023 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 fbf14386-f419-4e0a-94af-463bee34c281 35 fields · synced Jun 8, 2026