← Back to catalogue

ARK™ Pregabalin Urine Control

FDA UDI

Class I (US FDA UDI)

by Ark Diagnostics Inc

Identity

Trade Name
ARK™ Pregabalin Urine Control FDA UDI
Generic Name
Multiple anticonvulsant therapeutic drug monitoring IVD, control FDA UDI
Device Name
ARK™Pregabalin Urine Control is intended for use in quality control of the ARK™Pregabalin Urine Assay. FDA UDI
Model / Reference
5035-0003-00 FDA UDI
Description
ARK™Pregabalin Urine Control is intended for use in quality control of the ARK™Pregabalin Urine Assay. FDA UDI

Identifiers

Catalog Number
5035-0003-00 FDA UDI
Primary DI / UDI-DI
00858724003285 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™ Pregabalin Urine 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ark Diagnostics Inc

Sources (1)

  • FDA UDI 76efcfa3-0110-4a5c-83d8-3215c33e4308 36 fields · synced Jun 8, 2026