Argene SA
FranceFDA applicant, unverified
- Devices
- 1
What Argene SA makes
Argene SA manufactures the ADENOVIRUS R-GENE US, a diagnostic device designed for molecular detection of adenovirus in clinical samples, likely using real-time PCR or similar nucleic acid amplification technology.
The company’s portfolio is regulated under FDA 510(k) clearance as a Class II medical device, and the product is listed in the FDA’s 510(k) database. Argene SA is based in the United States.
Catalogue
Adenovirus R-Gene Us Ref K121942
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Argene SA have in the registry?
The registry currently lists 1 device for Argene SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Argene SA's devices?
Among its 1 most recently registered device, Argene SA has devices listed in FDA 510(k) (1 device).
What risk classes do Argene SA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Argene SA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Argene SA in the registry?
The most recently registered devices listed for Argene SA include ADENOVIRUS R-GENE US.