Legionella Cye Agar Base & Bcye Suppl

• • Terminated Z-1232-2015 FDA Class II ·initiated 5 Feb 2015

  Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.

• • Terminated Z-0578-2015 FDA Class II ·initiated 13 Nov 2014

  Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.

• • Terminated Z-0200-2015 FDA Class II ·initiated 17 Oct 2014

  Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.

• • Terminated Z-1112-2014 FDA Class II ·initiated 24 Jan 2014

  The product may contain high levels of microbial contamination

510(k) Number

K831469 ↗

FDA Product Code

JSK

Device Class

Class I

Regulation

21 CFR Part 866.2450

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. →