Latex Agglutination Assay, Rubella

FDA product code LQN · Class II (moderate risk) · 21 CFR 866.3510 · Microbiology

13510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K031490RubellacolLQN · Traditional Immunostics Inc.,07/16/2003SE
K970931Copalis Torc Total Antibody AssayLQN · Traditional Sienna Biotech, Inc.04/24/1997SE
K961784Copalis One Immunoassay System/Toxoplasma Gondii/Rubella/Cmv Total Antibody AssaysLQN · Traditional Sienna Biotech, Inc.10/31/1996SE
K954920Murex Rub-ExLQN · Traditional Murex Diagnostics, Inc.08/21/1996SE
K952544Colorslider RubellaLQN · Traditional Seradyn, Inc.01/17/1996SE
K912391Rubalex, ModificationLQN · Traditional Orion Corp.05/04/1992SE
K901637Resubmitted Modified RubalexLQN · Traditional Orion Corp.04/26/1990SE
K896433Modified RubagenLQN · Traditional Biokit USA, Inc.11/29/1989SE
K893755RubagenLQN · Traditional Biokit USA, Inc.08/21/1989SE
K861881Rubalex (Revised Version)LQN · Traditional Orion Corp.06/04/1986SE
K852788RubalexLQN · Traditional Orion Corp.03/12/1986SE
K844436Virogen Rubella Microtiter TestLQN · Traditional Armkel, LLC05/21/1985SE
K844435Virogen Rubella Slide TestLQN · Traditional Armkel, LLC05/20/1985SE