QVB

Biological Sterilization Indicator With Indirect Growth Detection

Product code

QVB

Device name

Biological Sterilization Indicator With Indirect Growth Detection

Device class

Class 2

21 CFR

21 CFR 880.2806

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

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.

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

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-06-18.

2 summaries are archived here for direct download.