Office of the Surgeon General, U.S. Army
Country not established
- Devices
- 1
What Office of the Surgeon General, U.S. Army makes
The Office of the Surgeon General, U.S. Army develops the Gamma Phage Lysis Assay, a diagnostic test used to identify *Bacillus anthracis* in clinical or environmental samples. This molecular-based method detects bacterial presence through phage-mediated cell lysis, supporting rapid identification for public health or military applications.
The Gamma Phage Lysis Assay is classified as a Class II device under U.S. regulations and is listed in the FDA’s 510(k) clearance registry. The product is authorised for use within the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Office of the Surgeon General, U.S. Army have in the registry?
The registry currently lists 1 device for Office of the Surgeon General, U.S. Army. Devices recorded under merged duplicate company entries are counted once.
Which registries list Office of the Surgeon General, U.S. Army's devices?
Among its 1 most recently registered device, Office of the Surgeon General, U.S. Army has devices listed in FDA 510(k) (1 device).
What risk classes do Office of the Surgeon General, U.S. Army's devices fall under?
Among its 1 most recently registered device, the classes recorded for Office of the Surgeon General, U.S. Army's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Office of the Surgeon General, U.S. Army in the registry?
The most recently registered devices listed for Office of the Surgeon General, U.S. Army include GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS.