Product code MZO— Microbiology
Anti-HCV Next
- Classification name
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Device class
- Class 2
- Regulation
- 21 CFR 866.3169
- Advisory panel
- Microbiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MZO
FDA has cleared devices under product code MZO between 2023 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2023
Top applicants under product code MZO
Adverse events under product code MZO
product code MZO- Malfunction
- 466
- Total
- 466
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MZO
Data sourced from openFDA. This site is unofficial and independent of the FDA.