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ARK™ Lamotrigine Assay

FDA UDI

Class II (US FDA UDI)

by Ark Diagnostics Inc

Identity

Trade Name
ARK™ Lamotrigine Assay FDA UDI
Generic Name
Multiple anticonvulsant therapeutic drug monitoring IVD, reagent FDA UDI
Device Name
The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Lamotrigine in human serum or plasma on automated clinical chemistry analyzers. Lamotrigine concentrations can be used as an aid in management of patients treated with Lamotrigine. The ARK™ Lamotrigine Assay consists of reagents RI anti-Lamotrigine polyclonal antibody with substrate and R2 Lamotrigine epitope labeled with bacterial G6PDH enzyme. FDA UDI
Model / Reference
5023-0001-00 FDA UDI
Description
The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Lamotrigine in human serum or plasma on automated clinical chemistry analyzers. Lamotrigine concentrations can be used as an aid in management of patients treated with Lamotrigine. The ARK™ Lamotrigine Assay consists of reagents RI anti-Lamotrigine polyclonal antibody with substrate and R2 Lamotrigine epitope labeled with bacterial G6PDH enzyme. FDA UDI

Identifiers

Catalog Number
5023-0001-00 FDA UDI
Primary DI / UDI-DI
00858724003025 FDA UDI
510(k) Number
K101305 FDA UDI
FDA Product Code
ORH FDA UDI
GMDN Term
Multiple anticonvulsant therapeutic drug monitoring IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3350 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, reagent

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

Similar devices

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

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 acecd279-3c9f-4a56-a97a-cd0dae5e3f94 37 fields · synced Jun 8, 2026