Biological Sterilization Indicator With Indirect Growth Detection

QVB · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2806

Classification

FDA Product Code: QVB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.2806
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown