Group A Streptococcus Nucleic Acid Amplification Assay System

OYZ · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3740

Classification

FDA Product Code: OYZ
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 866.3740
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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