FDA product code JRZ: Media, Culture, Amino Acid Assay
JRZ is the FDA product code for media, culture, amino acid assay. It is a Class I device, regulated under 21 CFR 866.2350 and reviewed by the Microbiology panel. Devices under JRZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Media, Culture, Amino Acid Assay |
| Device class | Class I |
| Regulation | 21 CFR 866.2350 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for JRZ devices
openFDA lists no recalls for product code JRZ.
Frequently asked questions
What is FDA product code JRZ?
JRZ is the FDA product code for media, culture, amino acid assay. It is a Class I device, regulated under 21 CFR 866.2350 and reviewed by the Microbiology panel.
What device class is JRZ?
Class I, regulation 21 CFR 866.2350. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JRZ
- Run a recall and safety report across every JRZ manufacturer
- Watch product code JRZ 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.