ARK™ Zonisamide Assay

FDA UDI

Class II (US FDA UDI)

by Ark Diagnostics Inc

Identity

Trade Name: ARK™ Zonisamide Assay FDA UDI
Generic Name: Zonisamide therapeutic drug monitoring IVD, reagent FDA UDI
Device Name: The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide. The ARK™ Zonisamide Assay consists of reagents RI anti-zonisamide polyclonal antibody with substrate and R2 zonisamide epitope labeled with bacterial G6PDH enzyme. FDA UDI
Model / Reference: 5022-0001-00 FDA UDI
Description: The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide. The ARK™ Zonisamide Assay consists of reagents RI anti-zonisamide polyclonal antibody with substrate and R2 zonisamide epitope labeled with bacterial G6PDH enzyme. FDA UDI

Identifiers

Catalog Number: 5022-0001-00 FDA UDI
Primary DI / UDI-DI: 00858724003018 FDA UDI
510(k) Number: K091884 FDA UDI
FDA Product Code: NWM FDA UDI
GMDN Term: Zonisamide 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Zonisamide therapeutic drug monitoring IVD, reagent

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

Cleared under the same submission

K091884 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Ark Diagnostics Inc

Sources (1)

FDA UDI 7beb2126-43ec-4871-96ef-6013baf6c82e 37 fields · synced May 30, 2026