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ARK™ Levetiracetam Calibrator

FDA UDI

Class II (US FDA UDI)

by Ark Diagnostics Inc

Identity

Trade Name
ARK™ Levetiracetam Calibrator FDA UDI
Generic Name
Levetiracetam therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
The ARK™ Levetiracetam Calibrator is intended for use in calibration of the ARK™ Levetiracetam Assay. FDA UDI
Model / Reference
5024-0002-00 FDA UDI
Description
The ARK™ Levetiracetam Calibrator is intended for use in calibration of the ARK™ Levetiracetam Assay. FDA UDI

Identifiers

Catalog Number
5024-0002-00 FDA UDI
Primary DI / UDI-DI
00858724003094 FDA UDI
510(k) Number
K091653 FDA UDI
FDA Product Code
DLJ FDA UDI
GMDN Term
Levetiracetam 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: Levetiracetam therapeutic drug monitoring IVD, calibrator

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

Similar devices

Also classified as Levetiracetam therapeutic drug monitoring IVD, calibrator.

Cleared under the same submission

K091653 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 a8cf738c-7d2d-4b82-99cc-0ba6bddcd5cc 37 fields · synced May 30, 2026