FDA Product Code QVB: Biological Sterilization Indicator With Indirect Growth Detection
A Biological Sterilization Indicator With Indirect Growth Detection Capabilities Is A Device Intended For Use By A Healthcare Provider To Accompany Products Being Sterilized Through A Sterilization Process To Monitor The Adequacy Of Sterilization. Detection Of Surviving Microorganisms Is Accomplished By A Method Other Than Direct Detection Of Growth Or Growth Products.
Leading manufacturers include Terragene S.A. and Steritec Products.
FDA 510(k) Cleared Biological Sterilization Indicator With Indirect Growth Detection Devices (Product Code QVB)
About Product Code QVB - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QVB since 2024, with 1 receiving FDA clearance (average review time: 507 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
QVB devices are reviewed by the General Hospital panel. Browse all General Hospital devices →