OZY

Chlamydophila Pneumoniae Dna Assay System

Product code: OZY
Device name: Chlamydophila Pneumoniae Dna Assay System
Device class: Class 2
21 CFR: 21 CFR 866.3980
Medical specialty: Microbiology
Marketing pathway: 510(K)

FDA classification definition

A qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens. Detection of Chlamydophila pneumoniae DNA aids in the diagnosis of Chlamydophila pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

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

Official FDA classification page: OZY

Classification and pathway per current FDA publications. Data from openFDA (CC0).