Identity
- Trade Name
- ARK™ Lacosamide Assay FDA UDI
- Generic Name
- Multiple anticonvulsant therapeutic drug monitoring IVD, reagent FDA UDI
- Device Name
- The ARK™ Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy. FDA UDI
- Model / Reference
- 5033-0001-00 FDA UDI
- Description
- The ARK™ Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy. FDA UDI
Identifiers
- Catalog Number
- 5033-0001-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003339 FDA UDI
- GMDN Term
- Multiple anticonvulsant therapeutic drug monitoring IVD, reagent FDA UDI
Classification
- 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, reagent
ARK™ Lacosamide Assay by Ark Diagnostics Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Ark Diagnostics Inc
Sources (1)
- FDA UDI d223a201-acb0-4449-aa91-27b96086f781 36 fields · synced May 30, 2026