Identity
- Trade Name
- ARK Topiramate Assay EUDAMEDARK™ Topiramate Assay FDA UDI
- Generic Name
- Multiple-therapy therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ARK Topiramate Assay EUDAMEDThe ARK™ Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy. FDA UDI
- Model / Reference
- 5015-0001-00 EUDAMEDFDA UDI
- Description
- The ARK™ Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy. FDA UDI
Identifiers
- Catalog Number
- 5015-0001-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003001 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00858724003001 EUDAMED
- 510(k) Number
- K083799 FDA UDI
- FDA Product Code
- NWM FDA UDI
- EMDN Code
- W0102080213 TOPIRAMATE EUDAMED
- GMDN Term
- Multiple-therapy therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3350 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
ARK Topiramate Assay by Ark Diagnostics Inc — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00858724003001 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- ARK Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000023925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 8f815b8f-cf15-4d4e-a2e8-eb8eeffec7e8 61 fields · synced May 30, 2026
- FDA UDI b55eccb4-73c6-46d9-8162-8fdfa169b3c3 37 fields · synced May 30, 2026