FDA device listing
Capillary Blood Specimen Collection Supplemental Pack,IQLung Specimen Collection Kit,Nodify Lung Specimen Collection Kit
FDA device listing 1085202103 · Biodesix, Inc.
Key facts
| Proprietary names | Capillary Blood Specimen Collection Supplemental Pack,IQLung Specimen Collection Kit,Nodify Lung Specimen Collection Kit |
|---|---|
| Owner/operator | Biodesix, Inc. |
| Owner/operator number | 10084036 |
| Product codes | PQD |
| Device names | PQD - Blood Specimen Collection Convenience Kit (Excludes Hiv) |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1675 |
| Review panels | Clinical Chemistry |
| Registered establishments | BIODESIX, INC. |
| Establishment registrations | 3011854503 |
| FEI numbers | 3011854503 |
| Establishment operations | Contract Manufacturer, 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