FDA device listing
Vstrip
FDA device listing 1872865294 · Panion & BF Biotech Inc
Key facts
| Proprietary names | Vstrip |
|---|---|
| Owner/operator | Panion & BF Biotech Inc |
| Owner/operator number | 10060384 |
| Product codes | GTY |
| Device names | GTY - Antigens, All Groups, Streptococcus Spp. |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3740 |
| Review panels | Microbiology |
| Registered establishments | Panion & BF Biotech Inc. Xizhi Second Factory |
| Establishment registrations | 3013296716 |
| FEI numbers | 3013296716 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Foreign Private Label Distributor, 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