FDA device listing
Advanced Home Semen Analysis,Mail-In Semen Analysis,Sapyen Test Kit
FDA device listing 1048270719 · Vito Health Pty Ltd
Key facts
| Proprietary names | Advanced Home Semen Analysis,Mail-In Semen Analysis,Sapyen Test Kit |
|---|---|
| Owner/operator | Vito Health Pty Ltd |
| Owner/operator number | 10086901 |
| Product codes | KDT |
| Device names | KDT - Container, Specimen Mailer And Storage, Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3250 |
| Review panels | Pathology |
| Registered establishments | VITO HEALTH PTY LTD |
| Establishment registrations | 3026062723 |
| FEI numbers | 3026062723 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database