Device type
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Product code PGX · Class II · 21 CFR 866.2680 · Microbiology
An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.
Recent 510(k)s
Aug 28, 2026
K260047
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
Roche Molecular Systems, Inc.
- PGX
- Class II
Recent recalls
No recalls in the archive for PGX.