PEJClass III

Salivary Estriol Test

Unknown

PEJ is the FDA product code for Salivary Estriol Test, a class III device type. FDA's definition for this code reads: "To detect and measure salivary estriol in pregnant women". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: PEJ
Device name: Salivary Estriol Test
FDA definition: To detect and measure salivary estriol in pregnant women.
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PEJ.

Recent clearances

Product code PEJ

FDA records hold no clearances under product code PEJ.

Recent recalls

Product code PEJ

Z-2836-2018Class IILower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.DRG Instruments GmbH / initiated 2016-07-14 / 169 kits

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)