FDA product code OUZ: Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
OUZ is the FDA product code for nucleic amplification assays for the detection of leishmania nucleic acids. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under OUZ. The average 510(k) review took 1057 days (median 1057).
Definition
Detection of Leishmania species in skin lesions.
Classification
| Field | Value |
|---|---|
| Device name | Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids |
| Device class | Class I |
| Regulation | 21 CFR 866.3870 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OUZ clearance
Top OUZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| U.S. Army Medical Research Institute of Infectious | 1 | 2011-05-25 |
Most recent OUZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081868 | U.S. Army Medical Research Institute of Infectious | SMART LEISH, MODEL LGM1-050 | 2011-05-25 | 1057 |
Recalls for OUZ devices
openFDA lists no recalls for product code OUZ.
Frequently asked questions
What is FDA product code OUZ?
OUZ is the FDA product code for nucleic amplification assays for the detection of leishmania nucleic acids. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel.
What device class is OUZ?
Class I, regulation 21 CFR 866.3870. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUZ?
Across 1 cleared submissions the average was 1057 days from receipt to decision (median 1057).
Which companies have the most OUZ clearances?
U.S. Army Medical Research Institute of Infectious (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OUZ
- Run a recall and safety report across every OUZ manufacturer
- Watch product code OUZ 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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