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

Microbiology · 3 clearances · 3 unique sponsors

Device class

Class II

Regulation 866.2680

Total clearances

2020-11-09 → 2026-08-28

Last 12 months

Unique sponsors

Definition

What is 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.

Classification details

Medical specialty

Microbiology

Review panel

Regulation number

866.2680

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Players

Sponsor	Clearances	Last 12 mo	Most recent
Diasorin Molecular, LLC	1	1	2026-06-15
Roche Molecular Systems, Inc.	1	1	2026-08-28
Mesa Biotech, Inc.	1	0	2020-11-09

Pulse

Date	K-number	Sponsor	Device
2026-08-28	K260047	Roche Molecular Systems, Inc.	cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
2026-06-15	K260333	Diasorin Molecular, LLC	LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
2020-11-09	K201269	Mesa Biotech, Inc.	Accula Strep A Test