LQNClass II
Latex Agglutination Assay, Rubella
Microbiology · 21 CFR 866.3510
MDR events1All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances13All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Other1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
13 clearances for this product code
- Immunostics Inc.,Jul 16, 2003
K031490 · RUBELLACOL
- Sienna Biotech, Inc.Apr 24, 1997
K970931 · COPALIS TORC TOTAL ANTIBODY ASSAY
- Sienna Biotech, Inc.Oct 31, 1996
K961784 · COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS
- Murex Diagnostics, Inc.Aug 21, 1996
K954920 · MUREX RUB-EX
- Seradyn, Inc.Jan 17, 1996
K952544 · COLORSLIDER RUBELLA
- Orion Corp.May 4, 1992
K912391 · RUBALEX, MODIFICATION
- Orion Corp.Apr 26, 1990
K901637 · RESUBMITTED MODIFIED RUBALEX
- Biokit USA, Inc.Nov 29, 1989
K896433 · MODIFIED RUBAGEN