Contract manufacturerContract sterilizerZenBio, Inc dba BioIVT, LLC (Durham, NC)North CarolinaHematologyClass I
ZenBio, Inc dba BioIVT, LLC
Contract manufacturer and sterilizer · Durham, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3017716384 (openFDA record; or search FDA's registration database)
- FEI number
- 3017716384
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Contract sterilizer
- Owner or operator
- BioIVT, LLC (FDA owner/operator no. 10094684)
- Registered address
- 3920 S Alston Ave, Durham, NC 27713
- Contract listings
- 1 device listings, 1 product codes, first listed Dec 16, 2025
- 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 |
|---|---|---|---|---|---|
| KIS | Sera, Animal And Human | Class I | Hematology | Contract manufacturing | Dec 16, 2025 |
| KIS | Sera, Animal And Human | Class I | Hematology | Contract sterilization | Dec 16, 2025 |