Data / Medical devices / Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System (PGX): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System (product code PGX, Class 2, 21 CFR 866.2680). 9 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on August 28, 2026, and lists 3 recall events (1 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- PGX
- Device class
- 2
- Regulation
- 866.2680
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Switzerland | 1 |
| Sweden | 1 |
| Canada | 1 |
Makers of Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | October 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Manufacturer for export, Specification developer | 2 | April 26, 2018 | 0 | 1 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer, Manufacturer for export | 2 | April 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 2 | June 15, 2026 | 0 | 1 | 1 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Manufacturer, Specification developer | 1 | May 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 1 | March 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 1 | November 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer | 1 | November 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 1 | November 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| BioFire Diagnostics, LLC | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cepheid AB | SOLNA Stockholm, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enercon Technologies | Gray, ME, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meridian Bioscience Canada Inc. | Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.