Identity
- Trade Name
- ARK™ Voriconazole II Assay FDA UDI
- Generic Name
- Voriconazole therapeutic drug monitoring IVD, reagent FDA UDI
- Device Name
- The ARK™ Voriconazole II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of voriconazole in human serum on automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 5030-0001-01 FDA UDI
- Description
- The ARK™ Voriconazole II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of voriconazole in human serum on automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 5030-0001-01 FDA UDI
- Primary DI / UDI-DI
- 00858724003223 FDA UDI
- GMDN Term
- Voriconazole 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: Voriconazole therapeutic drug monitoring IVD, reagent
ARK™ Voriconazole II Assay by Ark Diagnostics Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 bdecddc4-8223-4f75-af9e-3c11f580c892 36 fields · synced May 30, 2026