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Rubella IGG Antibody ELISA Test Sys

by Ortho Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K841200

Overview

This device is a rubella virus serological reagent designed to detect IgG antibodies to rubella virus in serum. It operates as an enzyme-linked immunosorbent assay (ELISA) system for qualitative or quantitative antibody measurement. The test utilizes specific antigen-antibody interactions to identify the presence of rubella IgG, supporting serological evaluation in clinical samples.

The device is supplied as a test system by Ortho Diagnostic Systems, Inc., intended for use in microbiology laboratory settings. It is classified as a Class 2 device under product code LFX and was authorized through the FDA 510(k) Traditional clearance pathway. The system is designed for in vitro diagnostic use and falls under regulatory classification 866.3510 for rubella virus serological reagents.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK841200 Date21 May 1984ClearedStatusActive

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 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LFX
Device Class
Class II
Regulation
21 CFR Part 866.3510
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the purpose of the Rubella IgG Antibody ELISA Test System?

    This device is designed to detect IgG antibodies to rubella virus in serum through enzyme-linked immunosorbent assay (ELISA), supporting serological evaluation in clinical samples for diagnostic purposes.

  • How is the Rubella IgG Antibody ELISA Test System supplied?

    The test system is supplied by Ortho Diagnostic Systems, Inc. as a complete in vitro diagnostic system intended for use in microbiology laboratory settings to perform qualitative or quantitative antibody measurements.

  • What is the regulatory classification of this device?

    The Rubella Igg Antibody ELISA Test System is classified as a Class 2 device under product code LFX and was authorized through the FDA 510(k) Traditional clearance pathway for in vitro diagnostic use.

  • What laboratory settings is this device designed for?

    This device is specifically designed for use in microbiology laboratory settings where serological evaluation of clinical samples for rubella IgG antibodies is performed as part of diagnostic testing procedures.