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ARK™ Pregabalin Urine Assay

FDA UDI

Class II (US FDA UDI)

by Ark Diagnostics Inc

Identity

Trade Name
ARK™ Pregabalin Urine Assay FDA UDI
Generic Name
Multiple anticonvulsant therapeutic drug monitoring IVD, reagent FDA UDI
Device Name
The ARK™ Pregabalin Urine Assay is a homogeneous enzyme immunoassay intended for the quantitative and/or semi-quantitative analysis of pregabalin in human urine. FDA UDI
Model / Reference
5035-0001-00 FDA UDI
Description
The ARK™ Pregabalin Urine Assay is a homogeneous enzyme immunoassay intended for the quantitative and/or semi-quantitative analysis of pregabalin in human urine. FDA UDI

Identifiers

Catalog Number
5035-0001-00 FDA UDI
Primary DI / UDI-DI
00858724003278 FDA UDI
FDA Product Code
NWM 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™ Pregabalin Urine 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.

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 5a648d6e-3e7c-4399-b227-a9d83635b187 36 fields · synced May 30, 2026