Identity
- Trade Name
- ARK™ Levetiracetam II Control FDA UDI
- Generic Name
- Levetiracetam therapeutic drug monitoring IVD, control FDA UDI
- Device Name
- ARK Levetiracetam II Control is intended for use in quality control of the ARK Levetiracetam II Assay. FDA UDI
- Model / Reference
- 5070-0003-00 FDA UDI
- Description
- ARK Levetiracetam II Control is intended for use in quality control of the ARK Levetiracetam II Assay. FDA UDI
Identifiers
- Catalog Number
- 5070-0003-00 FDA UDI
- Primary DI / UDI-DI
- 00812101030660 FDA UDI
- 510(k) Number
- K232522 FDA UDI
- FDA Product Code
- ORI FDA UDI
- GMDN Term
- Levetiracetam therapeutic drug monitoring IVD, control 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
No
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, control
ARK™ Levetiracetam II Control 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, control.
Cleared under the same submission
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 04637c63-31bb-4b98-a6e1-54a6903a5d6f 37 fields · synced May 31, 2026