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ARK™ Topiramate Calibrator

FDA UDI

Class II (US FDA UDI)

by Ark Diagnostics Inc

Identity

Trade Name
ARK™ Topiramate Calibrator FDA UDI
Generic Name
Multiple anticonvulsant therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
The ARK™ Topiramate Calibrator consists of a six-level set to calibrate the ARK™ Topiramate Assay. FDA UDI
Model / Reference
5015-0002-00 FDA UDI
Description
The ARK™ Topiramate Calibrator consists of a six-level set to calibrate the ARK™ Topiramate Assay. FDA UDI

Identifiers

Catalog Number
5015-0002-00 FDA UDI
Primary DI / UDI-DI
00858724003063 FDA UDI
510(k) Number
K083799 FDA UDI
FDA Product Code
DLJ FDA UDI
GMDN Term
Multiple anticonvulsant therapeutic drug monitoring IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3200 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, calibrator

ARK™ Topiramate Calibrator 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, calibrator.

Cleared under the same submission

K083799 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 e738f727-a865-4948-bc31-9c3d3944b122 37 fields · synced May 30, 2026