Reagin Antigen Suspension

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K822662 ↗

FDA Product Code

GMQ

Device Class

Class II

Regulation

21 CFR Part 866.3820

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Campylobacter Blood-Free Selective Agar Base

  Class I

  FDA 510(k) K850658 Active Cleared 20 Mar 1985

• Campylobacter Blood-Free Selective Agar Baseq

  Class I

  FDA 510(k) K850832 Active Cleared 29 Mar 1985

• Selenite Cystine Broth Base

  Not classified

  FDA 510(k) K841660 Active Cleared 14 May 1984

• Diagnostic Reagent Set-Rpla

  Class I

  FDA 510(k) K855233 Active Cleared 4 Nov 1986

• Staphylase Test

  Class I

  FDA 510(k) K874303 Active Cleared 6 Nov 1987

• X-Factor Discs

  Class I

  FDA 510(k) K802500 Active Cleared 12 Nov 1980

See all devices from Oxoid U.S.A., Inc. →

• What is Reagin Antigen Suspension used for?

  Reagin Antigen Suspension is a nontreponemal antigen preparation intended for in vitro diagnostic use in laboratory testing, specifically within the microbiology specialty, to detect antibodies in patient samples as part of serological testing procedures.

• How is Reagin Antigen Supplied and is it sterile or single-use?

  The device is supplied as a liquid suspension in a container for laboratory use; the provided data does not specify sterility or single-use status, so users must consult the manufacturer's labeling for details on handling, storage, and whether it is intended for single or multiple uses.

• What regulatory pathway was used for Reagin Antigen Suspension and what is its classification?

  Reagin Antigen Suspension received FDA 510(k) clearance (K822662) on September 21, 1982, as a substantially equivalent device under regulation 866.3820, and is classified as a Class 2 medical device with product code GMQ in the microbiology specialty.