MedtechSourcebook

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 codeDevice (FDA name)ClassCategoryRoleFirst listed
KISSera, Animal And HumanClass IHematologyContract manufacturingDec 16, 2025
KISSera, Animal And HumanClass IHematologyContract sterilizationDec 16, 2025

Other contract facilities of BioIVT, LLC