FDA device listing
PeriLynx System,PTDCheck,Rapid fFN 10Q System
FDA device listing 1154622692 · HOLOGIC, INC.
Key facts
| Proprietary names | PeriLynx System,PTDCheck,Rapid fFN 10Q System |
|---|---|
| Owner/operator | HOLOGIC, INC. |
| Owner/operator number | 9007676 |
| Product codes | LKV |
| Device names | LKV - Enzyme Immunoassay, Fetal Fibronectin |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LKV |
| Review panels | Clinical Chemistry |
| Registered establishments | Hologic, Inc. |
| Establishment registrations | 2024800 |
| FEI numbers | 2024800 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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