FDA Registration
Active
🇺🇸 United States
IQLung Specimen Collection Kit
Reg #: 3011854503
·
FEI: 3011854503
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BIODESIX, INC.
- Registration Number
- 3011854503
- FEI Number
- 3011854503
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 919 W Dillon Rd, Suite 100
- City
- Louisville
- State
- CO
- ZIP
- 80027
- Country
- US
Owner / Operator
- Firm Name
- Biodesix, Inc.
- Operator Number
- 10084036
- Address
- 919 W Dillon Rd, Suite 100
- City
- Louisville
- State
- CO
- Postal Code
- 80027
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2022-01-11 |
Proprietary Names
IQLung Specimen Collection Kit
Capillary Blood Specimen Collection Supplemental Pack
Nodify Lung Specimen Collection Kit
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)