Contract manufacturerUS SPECIALTY FORMULATIONS (Allentown, PA)PennsylvaniaGastroenterology and urologyClass II
US SPECIALTY FORMULATIONS
Contract manufacturer ยท Allentown, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010680515 (openFDA record; or search FDA's registration database)
- FEI number
- 3010680515
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- US SPECIALTY FORMULATIONS (FDA owner/operator no. 10084330)
- Registered address
- 1401 S Albert St, Allentown, PA 18103
- Contract listings
- 2 device listings, 2 product codes, first listed Feb 10, 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 |
|---|---|---|---|---|---|
| KDL | Set, Perfusion, Kidney, Disposable | Class II | Gastroenterology and urology | Contract manufacturing | Feb 10, 2022 |
| KDN | System, Perfusion, Kidney | Class II | Gastroenterology and urology | Contract manufacturing | Jan 12, 2026 |