Accelerate Diagnotics
Country not established
- Devices
- 1
What Accelerate Diagnotics makes
Accelerate Diagnostics produces the Accelerate Pheno system, a diagnostic platform designed for rapid microbial identification and antibiotic susceptibility testing, alongside the Accelerate Phenotest BC Kit for blood culture identification.
The company’s products are classified as Class II devices under FDA regulations and are authorised via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Accelerate Pheno system, Accelerate Phenotest BC Kit Ref DEN160032
Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Accelerate Diagnotics have in the registry?
The registry currently lists 1 device for Accelerate Diagnotics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accelerate Diagnotics's devices?
Among its 1 most recently registered device, Accelerate Diagnotics has devices listed in FDA 510(k) (1 device).
What risk classes do Accelerate Diagnotics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Accelerate Diagnotics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Accelerate Diagnotics in the registry?
The most recently registered devices listed for Accelerate Diagnotics include Accelerate Pheno system, Accelerate Phenotest BC Kit.