OYZ

Group A Streptococcus Nucleic Acid Amplification Assay System

Product code: OYZ
Device name: Group A Streptococcus Nucleic Acid Amplification Assay System
Device class: Class 1
21 CFR: 21 CFR 866.3740
Medical specialty: Microbiology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.

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

Official FDA classification page: OYZ

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