Identity
- Trade Name
- ARK™ Levetiracetam Assay FDA UDI
- Generic Name
- Levetiracetam therapeutic drug monitoring IVD, reagent FDA UDI
- Device Name
- The ARK™ Levetiracetam Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetiracetam concentrations can be used as an aid in management of patients treated with Levetiracetam. The ARK™ Levetiracetam Assay consists of reagents RI anti-Levetiracetam polyclonal antibody with substrate and R2 Levetiracetam epitope labeled with bacterial G6PDH enzyme. FDA UDI
- Model / Reference
- 5024-0001-00 FDA UDI
- Description
- The ARK™ Levetiracetam Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetiracetam concentrations can be used as an aid in management of patients treated with Levetiracetam. The ARK™ Levetiracetam Assay consists of reagents RI anti-Levetiracetam polyclonal antibody with substrate and R2 Levetiracetam epitope labeled with bacterial G6PDH enzyme. FDA UDI
Identifiers
- Catalog Number
- 5024-0001-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003032 FDA UDI
- 510(k) Number
- K091653 FDA UDI
- FDA Product Code
- ORI FDA UDI
- GMDN Term
- Levetiracetam 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: Levetiracetam therapeutic drug monitoring IVD, reagent
ARK™ Levetiracetam Assay by Ark Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K091653 also covers:
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 bf78a5e1-45ce-4a88-8fea-da0fb464e670 37 fields · synced Jun 6, 2026