QUJ

Automated Cryopreservation Storage System

Product code: QUJ
Device name: Automated Cryopreservation Storage System
Device class: Class 2
21 CFR: 21 CFR 884.6120
Medical specialty: Obstetrics/Gynecology
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QUJ

Classification and pathway per current FDA publications. Data from openFDA (CC0).