Biocoat, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Biocoat, Inc. makes
Biocoat, Inc. manufactures the PICSI Sperm Selection Device, a tool used for selecting sperm during assisted reproductive procedures, and the HBA Sperm-Hyaluronan Binding Assay, a diagnostic test to evaluate sperm binding to hyaluronan as an indicator of sperm quality.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Picsi Sperm Selection Device Ref K052457
Regimes: 510(k) Registry: 510(k)Hba Sperm-Hyaluronan Binding Assay Ref K032874
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biocoat, Inc. have in the registry?
The registry currently lists 2 devices for Biocoat, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocoat, Inc.'s devices?
Among its 2 most recently registered devices, Biocoat, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Biocoat, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biocoat, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biocoat, Inc. in the registry?
The most recently registered devices listed for Biocoat, Inc. include PICSI SPERM SELECTION DEVICE and HBA SPERM-HYALURONAN BINDING ASSAY.