Skip to content

Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody

by Ventana Medical Systems, Inc.

510(k) K110215

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110215 Date17 Dec 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3007-2018 FDA Class I initiated 2 Aug 2018

    Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MYA
Device Class
Class II
Regulation
21 CFR Part 864.1860
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody is a laboratory reagent intended for the qualitative detection of estrogen receptor antigen in sections of formalin-fixed, paraffin-embedded breast tissue. This rabbit monoclonal antibody is produced as a cell culture supernatant and is designed for use with VENTANA automated slide stainers and compatible detection kits.

The device is supplied as a ready-to-use solution and is intended for single-use applications. It is classified under product code MYA and has received FDA 510(k) clearance as substantially equivalent. The device is used in conjunction with VENTANA detection kits and ancillary reagents for immunohistochemistry applications in hematology.

Other devices from Ventana Medical Systems

See all devices from Ventana Medical Systems →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody used for?

    This laboratory reagent is intended for the qualitative detection of estrogen receptor antigen in sections of formalin-fixed, paraffin-embedded breast tissue, primarily used in immunohistochemistry applications in hematology.

  • How is the Confirm Anti-Estrogen Receptor (SP1) antibody supplied?

    The device is supplied as a ready-to-use solution and is produced as a cell culture supernatant. It is designed specifically for use with VENTANA automated slide stainers and compatible detection kits.

  • Is the Confirm Anti-Estrogen Receptor (SP1) antibody single-use or reusable?

    This antibody is intended for single-use applications only and should not be reused or stored for future use after opening or use in a procedure.

  • What regulatory clearance has the Confirm Anti-Estrogen Receptor (SP1) antibody received?

    The device has received FDA 510(k) clearance as substantially equivalent under product code MYA, with the clearance number K110215, indicating it meets the necessary regulatory requirements for its intended use.