Genova Diagnostics

FDA Device Registration & Listing · Asheville, NC, US · Registration 1055886

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
1055886
FEI Number
1000111208
Entity Name
Genova Diagnostics
City/State/Country
Asheville, NC, US
Establishment Address
63 Zillicoa St, Asheville, NC 28801, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GENOVA DIAGNOSTICS (Owner Number: 9008578)
Owner / Operator Contact Address
63 ZILLICOA ST., --, Asheville, NC 28801, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

INTESTINAL PERMEABILITY TEST SYSTE GREAT SMOKIES DIAGNOSTIC LABORATORY

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOC Colorimetric, Xylose Clinical Chemistry Class 1 862.1820 1993-12-10

Official Correspondent

Denise Montilla

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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Registration Number Establishment Name Location
1051901 CELL SCIENCE SYSTEMS, CORP. Deerfield Bch, FL, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1055886. Last updated year: 2026. Please use registration number 1055886 when referencing this establishment in official correspondence.
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