FDA product code PZN: Placental Growth Factor Test
PZN is the FDA product code for placental growth factor test. It is a Not classified device, reviewed by the Clinical Toxicology panel. Devices under PZN reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For quantitative determination of Placental Growth Factor (PlGF).
Classification
| Field | Value |
|---|---|
| Device name | Placental Growth Factor Test |
| Device class | Not classified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PZN devices
openFDA lists no recalls for product code PZN.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- S9055 — Procuren or other growth factor preparation to promote wound healing
Frequently asked questions
What is FDA product code PZN?
PZN is the FDA product code for placental growth factor test. It is a Not classified device, reviewed by the Clinical Toxicology panel.
What device class is PZN?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PZN
- Run a recall and safety report across every PZN manufacturer
- Watch product code PZN 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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