MZO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3169
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2021: 26 · 2022: 56 · 2023: 55 · 2024: 56 · 2025: 210 · 2026: 72
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Anti-HCV Next (K252424) | Abbott Laboratories | 2026-04-28 |
| Elecsys Anti-HCV II (08837031190) (K221693) | Roche Diagnostics | 2023-01-04 |
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Every clearance here is in the API, with alerts when new ones post.