FDA product code MZO: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
MZO is the FDA product code for assay, enzyme linked immunosorbent, hepatitis c virus. It is a Class II device, regulated under 21 CFR 866.3169 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under MZO, 2 in the last five years, from 2 different applicants. The average 510(k) review took 239 days (median 239); 270 days on average over the last three years. 11 PMA applications cite this product code. FDA has posted 7 recalls for MZO devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Device class | Class II |
| Regulation | 21 CFR 866.3169 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for MZO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 208 |
| 2026 | 1 | 270 |
Compare with all 510(k) review times · Search every MZO clearance
Top MZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 1 | 2026-04-28 |
| Roche Diagnostics | 1 | 2023-01-04 |
Most recent MZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252424 | Abbott Laboratories | Anti-HCV Next | 2026-04-28 | 270 |
| K221693 | Roche Diagnostics | Elecsys Anti-HCV II (08837031190) | 2023-01-04 | 208 |
Recalls for MZO devices
7 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-03-04.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code MZO?
MZO is the FDA product code for assay, enzyme linked immunosorbent, hepatitis c virus. It is a Class II device, regulated under 21 CFR 866.3169 and reviewed by the Microbiology panel.
What device class is MZO?
Class II, regulation 21 CFR 866.3169. Typical premarket route: 510(k).
How long does a 510(k) take for product code MZO?
Across 2 cleared submissions the average was 239 days from receipt to decision (median 239).
Which companies have the most MZO clearances?
Abbott Laboratories (1); Roche Diagnostics (1).
Have MZO devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2024-03-04.
Next steps
- Run an FDA pathway report with predicate devices for product code MZO
- Run a recall and safety report across every MZO manufacturer
- Watch product code MZO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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