Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005370583

FEI Number

3005370583

Entity Name

KORVIS LLC (DBA Ascential Medical & Life Sciences)

City/State/Country

Corvallis, OR, US

Establishment Address

2101 NE Jack London St, Corvallis, OR 97330, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Korvis, LLC (DBA Ascential Medical & Life Sciences) (Owner Number: 10045146)

Owner / Operator Contact Address

2101 NE Jack London Street, Corvallis, OR 97330, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cytovale System nCounter Digital Analyzer 5s Concerto Imager

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	2024-06-13
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2016-10-31
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2022-08-15

Official Correspondent

Jamie Maughan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Korvis, LLC (DBA Ascential Medical & Life Sciences)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

Similar Registrations

Registration Number	Establishment Name	Location
3005288662	Westec Plastics Corporation	Livermore, CA, US
3017448032	CYTOVALE, INC.	South San Francisco, CA, US
3010423292	COMAR LLC	Woodville, WI, US
3005269352	Invetech Pty Ltd	Mount Waverley Victoria, AU
3002773840	BioFire Diagnostics, LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005370583. Last updated year: 2026. Please use registration number 3005370583 when referencing this establishment in official correspondence.