Identity
- Trade Name
- ARK™ Zonisamide Control FDA UDI
- Generic Name
- Zonisamide therapeutic drug monitoring IVD, control FDA UDI
- Device Name
- The ARK™ Zonisamide Control is intended for use in quality control of the ARK™Zonisamide Assay. FDA UDI
- Model / Reference
- 5022-0003-00 FDA UDI
- Description
- The ARK™ Zonisamide Control is intended for use in quality control of the ARK™Zonisamide Assay. FDA UDI
Identifiers
- Catalog Number
- 5022-0003-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003131 FDA UDI
- 510(k) Number
- K091884 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Zonisamide therapeutic drug monitoring IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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: Zonisamide therapeutic drug monitoring IVD, control
ARK™ Zonisamide Control by Ark Diagnostics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K091884 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 I | Pending data |
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Manufacturer
- Manufacturer
- Ark Diagnostics Inc
Sources (1)
- FDA UDI e5c9a519-289f-43e2-bcc4-36fdcaec99b4 37 fields · synced May 30, 2026