FDA product code OYZ: Group A Streptococcus Nucleic Acid Amplification Assay System
OYZ is the FDA product code for group a streptococcus nucleic acid amplification assay system. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under OYZ. The average 510(k) review took 65 days (median 65).
Definition
An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.
Classification
| Field | Value |
|---|---|
| Device name | Group A Streptococcus Nucleic Acid Amplification Assay System |
| Device class | Class I |
| Regulation | 21 CFR 866.3740 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OYZ clearance
Top OYZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Bioscience, Inc. | 1 | 2012-09-13 |
Most recent OYZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122019 | Meridian Bioscience, Inc. | STREPTOCOCCUS APP. SEROLOGICAL REAGENTS | 2012-09-13 | 65 |
Recalls for OYZ devices
openFDA lists no recalls for product code OYZ.
Frequently asked questions
What is FDA product code OYZ?
OYZ is the FDA product code for group a streptococcus nucleic acid amplification assay system. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel.
What device class is OYZ?
Class I, regulation 21 CFR 866.3740. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYZ?
Across 1 cleared submissions the average was 65 days from receipt to decision (median 65).
Which companies have the most OYZ clearances?
Meridian Bioscience, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OYZ
- Run a recall and safety report across every OYZ manufacturer
- Watch product code OYZ 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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