PUJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Voriconazole Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3970
- Medical specialty
- Clinical Toxicology
- FDA definition
- A voriconazole test system is a device intended to measure voriconazole in human serum. Measurements obtained by this device are used in monitoring levels of voriconazole to ensure appropriate therapy.
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| Record | Firm | Date |
|---|---|---|
| ARK Voriconazole II Assay Test System (DEN160033) | Ark Diagnostics, Inc. | 2017-05-05 |
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Every clearance here is in the API, with alerts when new ones post.