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Abbott Er-Eia Monoclonal Diag. Kit

by Abbott Laboratories PMA

Withdrawn United States

PMA P850029

Overview

This device is a Kit, Assay, Estrogen Receptor (OpenFDA classification), designed for the qualitative detection of estrogen receptors in human breast tissue. It employs a monoclonal antibody-based enzyme immunoassay (EIA) to measure estrogen receptor presence, aiding in the assessment of hormone receptor status for breast cancer diagnosis and treatment planning.

The Abbott ER-EIA Monoclonal Diagnostic Kit is intended for use in clinical chemistry laboratories under sterile conditions. Supplied as a single-use diagnostic kit, it requires proper storage at controlled temperatures and adherence to manufacturer instructions for specimen collection and slide preparation. Authorized under FDA_PMA (PMA number P850029), it complies with regulatory requirements for device class 3 (regulation number 864.1860) and is distributed under product code LPJ. Minor labeling updates have been approved to mitigate interference risks from dyes like methylene blue.

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

Regulatory status

as of 26 Oct 2026

Withdrawn since 17 Oct 1988. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP850029 Date17 Oct 1988Approval withdrawnStatusWithdrawn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 AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Withdrawn

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

Specification

PMA

Generic Name
KIT, ASSAY, ESTROGEN RECEPTOR
PMA Number
FDA Product Code
LPJ
Regulation
21 CFR Part 864.1860
Advisory Committee
Clinical Chemistry
FDA Decision
APWD Approval withdrawn

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