System, Test, Systemic Lupus Erythematosus

FDA product code DHC · Class II (moderate risk) · 21 CFR 866.5820 · Immunology

16510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K001352Reaads Igg Anti-Prothrombin Semi-Quantitative Test KitDHC · Traditional Corgenix, Inc.04/09/2001SE
K001398Reaads Igm Anti-Prothrombin Semi-Quantitative Test KitDHC · Traditional Corgenix, Inc.03/30/2001SE
K930421Elias Dsdna AbsDHC · Traditional Elias U.S.A., Inc.03/10/1993SE
K930247Human A-Ds DNA Eia Kit for Diagnostic UseDHC · Traditional The Binding Site, Ltd.03/10/1993SE
K914801Immunowell Dsdna Antibody TestDHC · Traditional General Biometrics, Inc.12/09/1991SE
K885048Access R-Clone Ana Profile AssayDHC · Traditional Lipogen, Inc.01/24/1989SE
K872910Immuno/SleDHC · Traditional Immunostics Co., Inc.08/12/1987SE
K821385Sero/Tex Le TestDHC · Traditional Texas Immunology, Inc.05/28/1982SE
K810981Anti Ndna Immunoflourescent Test SysDHC · Traditional Immuno-Products Industries04/29/1981SE
K810226Sle Anti-N-Dna Latex TestDHC · Traditional Icl Scientific02/09/1981SE
K800992Cordia NPDHC · Traditional Cordis Corp.05/08/1980SE
K800991Cordia NDHC · Traditional Cordis Corp.05/08/1980SE
K800605Ana Latex Slide TestDHC · Traditional Biologics Intl., Inc.04/02/1980SE
K790257Systemic LupusDHC · Traditional Icl Scientific03/15/1979SE
K790106Iif-A-N-Dna Test KitDHC · Traditional Medica Corp.03/15/1979SE
K782129Lupo-TecDHC · Traditional Armkel, LLC03/12/1979SE

Recalls

RecallProductFirmInitiated
Z-1145-2010 BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot…The firm received customer complaints of microbial contamination in Positive Controls in its… Bio-Rad Laboratories Inc07/14/2009Terminated