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IgM Rheumatoid Factor Test Kit

by Breit Laboratories, Inc. 510(k)

Active United States

510(k) K851099

Overview

The IgM Rheumatoid Factor Test Kit is an immunological test system designed to detect rheumatoid factor (IgM antibodies to immunoglobulins) in serum, body fluids, or tissues using immunochemical techniques. It aids in the diagnostic evaluation of rheumatoid arthritis by quantifying these antibodies through validated laboratory methods.

This device is supplied as a single-use diagnostic kit and is intended for use in clinical laboratory settings under regulated conditions. It is classified under 21 CFR 866.5775 and holds an FDA 510(k) clearance (K851099) for substantial equivalence. No MRI safety or sterility specifications are noted in the regulatory data.

AI-generated from registry data, 19 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 NumberK851099 Date25 Apr 1985ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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
DHR
Device Class
Class II
Regulation
21 CFR Part 866.5775
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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