Antibodies Incorporated

FDA Device Registration & Listing · Davis, CA, US · Registration 3032523590

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
3032523590
FEI Number
3032523590
Entity Name
Antibodies Incorporated
City/State/Country
Davis, CA, US
Establishment Address
1460 Drew Ave Ste 300, Davis, CA 95618, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Antibodies Incorporated (Owner Number: 2914537)
Owner / Operator Contact Address
25242 County Road 95, PO Box 1560, Davis, CA 95616, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CrithiDNA AntiNuclear Antibody Test (ANA)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2012-06-27
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2007-12-04

Official Correspondent

Nira Azulai

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
2914537 ANTIBODIES INCORPORATED DAVIS, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K880742 Inova Diagnostics, Inc. NOVA LITE(TM) DSDNA 1988-03-25

Similar Registrations

Registration Number Establishment Name Location
3003268355 EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG Luebeck Schleswig-Holstein, DE
2016706 Bio-Rad Laboratories Inc. IRVINE, CA, US
3010127294 Bio-Rad Laboratories Inc. Irvine, CA, US
2914537 ANTIBODIES INCORPORATED DAVIS, CA, US
3015376545 IMMCO DIAGNOSTICS, INC. Williamsville, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032523590. Last updated year: 2026. Please use registration number 3032523590 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.