DeviceClearance

Product code PQZ— Microbiology

Granada Medium

Classification name
Gbs Culture Media, Selective And Differential
Device class
Class 1
Regulation
21 CFR 866.2360
Advisory panel
Microbiology
Total cleared
4
First cleared
Most recent

FDA classification definition

“Culture Medium for GBS Detection”

— U.S. Food and Drug Administration, device classification record for product code PQZ under 21 CFR 866.2360, via openFDA

Market context for product code PQZ

FDA has cleared 4 devices under product code PQZ between 2017 and 2018, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code PQZ

Recent clearances under product code PQZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.