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CEA-EIA System

by Abbott Laboratories PMA

Active United States

PMA P830066

Overview

The CEA-EIA System is an immunoassay device designed for the quantitative measurement of carcinoembryonic antigen (CEA) in human serum or plasma. Classified as a System, Test, Carcinoembryonic Antigen under the FDA’s nomenclature, it operates via enzyme immunoassay (EIA) principles to detect and quantify CEA levels, a biomarker often monitored in cancer screening and patient management.

This device is supplied as a single-use diagnostic test kit, intended for use in clinical laboratories or hospital settings. It requires no special sterility beyond standard laboratory practices and is regulated under FDA PMA (Premarket Approval) with PMA number P830066. The system is categorized under device class 2 and adheres to regulation number 866.6010, with multiple registration numbers (e.g., 8023060, 2517506) for tracking. Storage and handling follow standard immunoassay protocols, as specified in the accompanying instructions.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP830066 Date7 Jul 1986ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

PMA

Full name
Abbott Cea-Eia
Trade Name
Abbott Cea-Eia Kit
Generic Name
SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
PMA Number
FDA Product Code
DHX
Device Class
Class II
Regulation
21 CFR Part 866.6010
Advisory Committee
Immunology
FDA Decision
APPR Approved
PMA Supplement
S003

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