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

FDA product code PGX · 9 cleared devices

Class 2 Microbiology

Regulation: 21 CFR 866.2680
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2016-10-25 – 2026-08-28

An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.

PGX 2026-08-28

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