CYTOVALE, INC.

FDA Device Registration & Listing · South San Francisco, CA, US · Registration 3017448032

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
3017448032
FEI Number
3017448032
Entity Name
CYTOVALE, INC.
City/State/Country
South San Francisco, CA, US
Establishment Address
2 Tower Pl Fl 18, South San Francisco, CA 94080, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Cytovale, Inc. (Owner Number: 10088591)
Owner / Operator Contact Address
2 Tower Place, 18th Floor, South San Francisco, CA 94080, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220991
PMA Number
N/A

All Registered Proprietary Names

IntelliSep Cartridge IntelliSep Cartridge IntelliSep test Cytovale Cleanse Cytovale Diluent Cytovale System Cytovale Reagent Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QUT Deformability Cytometry For Sepsis Risk Assessment Microbiology Class 2 866.3215 2025-11-21
QUT Deformability Cytometry For Sepsis Risk Assessment Microbiology Class 2 866.3215 2023-08-23

Official Correspondent

Sarah Esterquest

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017448032. Last updated year: 2026. Please use registration number 3017448032 when referencing this establishment in official correspondence.
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