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CEA-Roche EIA

by Roche Diagnostics GmbH Germany PMA

PMA P840027

Product code DHX

Overview

This device is an Enzyme Immunoassay (EIA) System for Carcinoembryonic Antigen (CEA), classified under the nomenclature for immunology diagnostics. It quantifies CEA levels in serum or plasma, aiding in the monitoring of colorectal cancer, monitoring treatment response, and detecting recurrence in patients with known malignancy.

The CEA-Roche EIA is supplied as a single-use in vitro diagnostic reagent kit, intended for use in clinical laboratories. It requires no special storage conditions beyond refrigeration (2–8°C) and is compatible with standard laboratory equipment. Authorized under FDA_PMA (P840027) and regulated under 21 CFR 866.6010, this system adheres to strict immunology testing protocols for accurate CEA measurement.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

Withdrawn since 13 May 1985. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP840027 Date13 May 1985Approval withdrawnStatusWithdrawn

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 America
  • Withdrawn
  • Not covered

United States — FDA PMA Withdrawn

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

PMA · synced 6 Oct 2026

Full name
Cea-Roche(R) Eia
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
APWD Approval withdrawn

Other devices from Roche Diagnostics GmbH

See all devices from Roche Diagnostics GmbH →

Questions

  • What clinical scenarios is the CEA-ROCHE® EIA system primarily used for in patient monitoring?

    The CEA-ROCHE® EIA system is designed to quantify carcinoembryonic antigen (CEA) levels in serum or plasma, which helps clinicians monitor colorectal cancer progression, evaluate treatment response, and detect recurrence in patients with known malignancy. It is not intended for general screening but rather for follow-up in patients already diagnosed with cancer.

  • Is the CEA-ROCHE® EIA kit single-use or reusable, and what storage conditions are required?

    The CEA-ROCHE® EIA is supplied as a single-use in vitro diagnostic reagent kit. It requires standard refrigeration between 2–8°C and does not need any additional storage precautions beyond this temperature range, making it compatible with typical clinical laboratory environments.

  • How is this device regulated, and what does that mean for its use in clinical settings?

    The CEA-ROCHE® EIA is authorized under an FDA Premarket Approval (PMA) with the number P840027 and regulated under 21 CFR 866.6010. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use in immunology diagnostics, specifically for quantifying CEA levels in serum or plasma.

  • Are there multiple versions or models of this device, and if so, how do they differ?

    The CEA-ROCHE® EIA system is associated with multiple registration numbers and FEI numbers, indicating it may have different lot or variant identifiers for manufacturing or distribution purposes. However, the core functionality—quantifying CEA in serum/plasma—remains consistent across these versions. Clinicians should verify the specific lot or variant with the manufacturer if precise model differences are required.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P840027 24 fields · synced 6 Oct 2026