QYD
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Adalimumab Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3115
- Medical specialty
- Clinical Toxicology
- FDA definition
- An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Procise ADL (DEN220023) | Procisedx, Inc. | 2023-09-29 |
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Every clearance here is in the API, with alerts when new ones post.