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ARK™ Lamotrigine Control

FDA UDI

Class I (US FDA UDI)

by Ark Diagnostics Inc

Identity

Trade Name
ARK™ Lamotrigine Control FDA UDI
Generic Name
Multiple anticonvulsant therapeutic drug monitoring IVD, control FDA UDI
Device Name
The ARK™ Lamotrigine Control is intended for use in quality control of the ARK™Lamotrigine Assay. FDA UDI
Model / Reference
5023-0003-00 FDA UDI
Description
The ARK™ Lamotrigine Control is intended for use in quality control of the ARK™Lamotrigine Assay. FDA UDI

Identifiers

Catalog Number
5023-0003-00 FDA UDI
Primary DI / UDI-DI
00858724003148 FDA UDI
510(k) Number
K101305 FDA UDI
FDA Product Code
LAS FDA UDI
GMDN Term
Multiple anticonvulsant therapeutic drug monitoring 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

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

Yes

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

Category: Multiple anticonvulsant therapeutic drug monitoring IVD, control

ARK™ Lamotrigine Control by Ark Diagnostics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple anticonvulsant therapeutic drug monitoring IVD, control.

Cleared under the same submission

K101305 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ark Diagnostics Inc

Sources (1)

  • FDA UDI 0de3bae7-a2fc-44fd-be31-546e4c487822 37 fields · synced May 30, 2026