PGX · Class II · 21 CFR 866.2680

FDA Product Code PGX: Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System

An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From Symptomatic Patients.

13
Total
12
Cleared
119d
Avg days
2014
Since

FDA 510(k) Cleared Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System Devices (Product Code PGX)

13 devices
1–13 of 13
No devices found for this product code.

About Product Code PGX - Regulatory Context