PGX

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Product code

PGX

Device name

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Device class

Class 2

21 CFR

21 CFR 866.2680

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

15 (all years; only the last 3 years are listed here)

FDA classification definition

An in vitro diagnostic test for the detection of Group A, C and G 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).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-08-28.

2 summaries are archived here for direct download.