Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039436068

FEI Number

3039436068

Entity Name

BIOIVT, LLC

City/State/Country

Woodbury, NY, US

Establishment Address

175 Crossways Park Drive W, Suite 200, Woodbury, NY 11797, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Repack or Relabel 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BioIVT Human AB Serum 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
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	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
3017716384	ZenBio, Inc dba BioIVT, LLC	Durham, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832690	Sigma Chemical Co.	MINIMUM ESSENTIAL MED. EAGLE M0268	1983-09-12
K861867	Hazleton Research Products, Inc.	MEM ALPHA EAGLE MEDIUM	1986-05-29
K821916	Dutchland Laboratories, Inc.	IMPROVED MEM-RICHTER'S POWDER MODIF.	1982-07-27
K810767	Dutchland Laboratories, Inc.	RPMI 1640 MEDIUM	1981-05-08

Similar Registrations

Registration Number	Establishment Name	Location
1932313	CENTRAL BIOMEDIA, INC.	LENEXA, KS, US
3006236690	GEMINI BIOPRODUCTS LLC	West Sacramento, CA, US
9710594	MOREGATE EXPORTS PTY LTD	brisbane Queensland, AU
3017716384	ZenBio, Inc dba BioIVT, LLC	Durham, NC, US
9710646	MOREGATE EXPORTS LTD	HAMILTON Northland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039436068. Last updated year: 2026. Please use registration number 3039436068 when referencing this establishment in official correspondence.