Bioshaf, Ltd.
Country not established
- Devices
- 1
What Bioshaf, Ltd. makes
Bioshaf, Ltd. manufactures the General Semen Analysis (GSA) Kit, a diagnostic tool designed for evaluating semen samples in clinical settings. The kit supports laboratory assessments of semen quality, including parameters such as sperm count, motility, and morphology.
The GSA Kit is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
General Semen Analysis (Gsa) Kit Ref K024337
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioshaf, Ltd. have in the registry?
The registry currently lists 1 device for Bioshaf, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioshaf, Ltd.'s devices?
Among its 1 most recently registered device, Bioshaf, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Bioshaf, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bioshaf, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioshaf, Ltd. in the registry?
The most recently registered devices listed for Bioshaf, Ltd. include GENERAL SEMEN ANALYSIS (GSA) KIT.