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.
Leading manufacturers include Cepheid, Alere Scarborough, Inc. and Genepoc, Inc..
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
Cleared
Nov 09, 2020
Accula Strep A Test
Mesa Biotech, Inc.
Microbiology
181d
Cleared
Mar 06, 2019
GenePOC Strep A
Genepoc, Inc.
Microbiology
92d
Cleared
May 02, 2018
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
Alere Scarborough, Inc.
Microbiology
155d
Cleared
Apr 26, 2018
Xpert Xpress Strep A
Cepheid
Microbiology
177d