ZenBio, Inc dba BioIVT, LLC

FDA Device Registration & Listing · Durham, NC, US · Registration 3017716384

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017716384
FEI Number
3017716384
Entity Name
ZenBio, Inc dba BioIVT, LLC
City/State/Country
Durham, NC, US
Establishment Address
3920 S Alston Ave, Durham, NC 27713, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
BioIVT, LLC (Owner Number: 10094684)
Owner / Operator Contact Address
175 Crossways Park Drive W, Suite 200, Woodbury, NY 11797, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BioIVT Human AB Serum

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KIS Sera, Animal And Human Hematology Class 1 864.2800 2025-12-16

Official Correspondent

Stephanie Shipley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioIVT, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3039436068 BIOIVT, LLC Woodbury, NY, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017716384. Last updated year: 2026. Please use registration number 3017716384 when referencing this establishment in official correspondence.
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