Biovire, Inc.

FDA Device Registration & Listing · Brighton, MI, US · Registration 3011292417

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
3011292417
FEI Number
3011292417
Entity Name
Biovire, Inc.
City/State/Country
Brighton, MI, US
Establishment Address
12501 E. Grand River, Brighton, MI 48116, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Biovire, Inc. (Owner Number: 10059698)
Owner / Operator Contact Address
12501 E. Grand River, Brighton, MI 48116, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OnsetEZ pH Buffer Onset Sodium Bicarbonate, 8.4% pH Buffer Solution SYSTEM, PERFUSION, KIDNEY

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2025-06-04
JCC Ph Buffer Pathology Class 1 864.4010 2019-02-12
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2019-09-10

Official Correspondent

Steve Rhoades

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K013575 Organ Recovery Systems, Inc. KPS-I, THE KIDNEY PERFUSION SOLUTION 2002-01-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011292417. Last updated year: 2026. Please use registration number 3011292417 when referencing this establishment in official correspondence.
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