Identity
- Trade Name
- ARK™ Oxcarbazepine Metabolite Assay FDA UDI
- Generic Name
- Multiple anticonvulsant therapeutic drug monitoring IVD, reagent FDA UDI
- Device Name
- The ARK™ Oxcarbazepine Metabolite Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy. FDA UDI
- Model / Reference
- 5032-0001-00 FDA UDI
- Description
- The ARK™ Oxcarbazepine Metabolite Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy. FDA UDI
Identifiers
- Catalog Number
- 5032-0001-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003308 FDA UDI
- 510(k) Number
- K153596 FDA UDI
- FDA Product Code
- POX FDA UDI
- GMDN Term
- Multiple anticonvulsant therapeutic drug monitoring IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3645 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, reagent
ARK™ Oxcarbazepine Metabolite Assay by Ark Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple anticonvulsant therapeutic drug monitoring IVD, reagent.
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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 9ff1dd7a-f5e3-4e68-b191-2514397625f6 37 fields · synced May 30, 2026