Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

OWP · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2805

Classification

FDA Product Code: OWP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.2805
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 1

Source

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