FDA product code MIZ: Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
MIZ is the FDA product code for enzyme linked immunoabsorbent assay, histoplasma capsulatum. It is a Class II device, regulated under 21 CFR 866.3320 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under MIZ, from 2 different applicants. The average 510(k) review took 323 days (median 323).
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum |
| Device class | Class II |
| Regulation | 21 CFR 866.3320 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MIZ clearance
Top MIZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immuno-Mycologics, Inc. | 1 | 2011-07-19 |
| Meridian Diagnostics, Inc. | 1 | 1992-07-30 |
Most recent MIZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101407 | Immuno-Mycologics, Inc. | ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 | 2011-07-19 | 426 |
| K915700 | Meridian Diagnostics, Inc. | PERMIER HISTOPLASMA | 1992-07-30 | 220 |
Recalls for MIZ devices
openFDA lists no recalls for product code MIZ.
Frequently asked questions
What is FDA product code MIZ?
MIZ is the FDA product code for enzyme linked immunoabsorbent assay, histoplasma capsulatum. It is a Class II device, regulated under 21 CFR 866.3320 and reviewed by the Microbiology panel.
What device class is MIZ?
Class II, regulation 21 CFR 866.3320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MIZ?
Across 2 cleared submissions the average was 323 days from receipt to decision (median 323).
Which companies have the most MIZ clearances?
Immuno-Mycologics, Inc. (1); Meridian Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MIZ
- Run a recall and safety report across every MIZ manufacturer
- Watch product code MIZ 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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