Quality Control Slides

FDA product code LJG · Class I (low risk) · 21 CFR 866.2660 · Microbiology

27510(k) clearances
0PMA approvals
4recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K943228Microsporidium Control SetLJG · Traditional Meridian Diagnostics, Inc.10/27/1994SE
K924893Microsporidium Control SlideLJG · Traditional Scientific Device Laboratory, Inc.01/15/1993SE
K890718Gram Stain Control SlideLJG · Traditional Scientific Device Laboratory, Inc.03/16/1989SE
K890670Cryptosporidium Control SlideLJG · Traditional Scientific Device Laboratory, Inc.03/16/1989SE
K890616Bion Direct Identification Control SlideLJG · Traditional Bion Ent., Ltd.02/17/1989SE
K883571Histo-Check Parasitic Control SlidesLJG · Traditional Val Tech Diagnostics, Inc.10/06/1988SE
K883570Histo-Check Fungal Control SlidesLJG · Traditional Val Tech Diagnostics, Inc.10/06/1988SE
K883569Histo-Check Gram Negative SlidesLJG · Traditional Val Tech Diagnostics, Inc.10/06/1988SE
K883568Histo-Check Acid Fast SlidesLJG · Traditional Val Tech Diagnostics, Inc.10/06/1988SE
K883567Histo-Check Legionella Control SlidesLJG · Traditional Val Tech Diagnostics, Inc.10/06/1988SE
K883208Histo-Check SlidesLJG · Traditional Val Tech Diagnostics, Inc.08/25/1988SE
K881112Fungi Histology Control SlidesLJG · Traditional Sigma Diagnostics, Inc.04/21/1988SE
K881109Spirochetes Histology Control SlidesLJG · Traditional Sigma Diagnostics, Inc.04/21/1988SE
K881106Acid Fast Bacilli Histology Control SlidesLJG · Traditional Sigma Diagnostics, Inc.04/21/1988SE
K881110Legionella Pneumophilla Histology Control SlidesLJG · Traditional Sigma Diagnostics, Inc.04/12/1988SE
K881108Pneumocystis Carinii Histology Control SlidesLJG · Traditional Sigma Diagnostics, Inc.04/12/1988SE
K881111Intracellular/Extracellular Iron Histology ControlLJG · Traditional Sigma Diagnostics, Inc.03/30/1988SE
K881107Intracellular Amyloid Histology Control SlidesLJG · Traditional Sigma Diagnostics, Inc.03/30/1988SE
K880962Ats Cryptosporidium Stain Control SlidesLJG · Traditional Alpha-Tec Systems, Inc.03/30/1988SE
K840517Protozoa Stain ControlLJG · Traditional Scientific Device Laboratory, Inc.03/09/1984SE
K840516Metachromatic Granule Stain ControlLJG · Traditional Scientific Device Laboratory, Inc.03/09/1984SE
K840515Acid Fast Bacilli Stain ControlLJG · Traditional Scientific Device Laboratory, Inc.03/09/1984SE
K830134Q-Check Reagent StandardsLJG · Traditional Lab Ability, Inc.01/09/1983SE
K823706Ats Afb Stain Control SlideLJG · Traditional Alpha-Tec Systems, Inc.01/07/1983SE
K823705Ats Parasitology Stain Control SlideLJG · Traditional Alpha-Tec Systems, Inc.01/07/1983SE
K823704Ats Gram Stain Control SlideLJG · Traditional Alpha-Tec Systems, Inc.01/07/1983SE
K822604Acid Fast Quality Control SlidesLJG · Traditional Medastat Scientific Corp.09/28/1982SE

Recalls

RecallProductFirmInitiated
Z-1328-2019 Class IICS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA…May show diminished performance prior to its established expiration date resulting in an invalid control… Opgen Inc03/18/2019Terminated
Z-2439-2018 Class IIAdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF…Possible diminished performance prior to its established expiration date. Opgen Inc05/14/2018Terminated
Z-1021-2013 Class IIMicrobiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium…Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and… Microbiologics Inc02/11/2013Terminated
Z-1936-2012 Class IIMicrobiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides…Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative… Microbiologics Inc05/29/2012Terminated