FDA product code PEJ: Salivary Estriol Test
PEJ is the FDA product code for salivary estriol test. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under PEJ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for PEJ devices.
Definition
To detect and measure salivary estriol in pregnant women.
Classification
| Field | Value |
|---|---|
| Device name | Salivary Estriol Test |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PEJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-07-14.
Frequently asked questions
What is FDA product code PEJ?
PEJ is the FDA product code for salivary estriol test. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is PEJ?
Class III. Typical premarket route: PMA.
Have PEJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-07-14.
Next steps
- Run an FDA pathway report with predicate devices for product code PEJ
- Run a recall and safety report across every PEJ manufacturer
- Watch product code PEJ 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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