Contract manufacturerBIODESIX, INC. (Louisville, CO)ColoradoClinical chemistryClass II
BIODESIX, INC.
Contract manufacturer ยท Louisville, CO
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3011854503 (openFDA record; or search FDA's registration database)
- FEI number
- 3011854503
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Biodesix, Inc. (FDA owner/operator no. 10084036)
- Registered address
- 919 W Dillon Rd, Suite 100, Louisville, CO 80027
- Contract listings
- 1 device listings, 1 product codes, first listed Jan 11, 2022
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Class II | Clinical chemistry | Contract manufacturing | Jan 11, 2022 |