Immunoglobulin A Kappa Heavy & Light Chain Combined
Immunology · 21 CFR 866.5510
Intended for the in-vitro quantification of iga kappa concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- The Binding Site Group , Ltd.Jun 16, 2016
K160819 · Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
- The Binding Site Group , Ltd.Nov 6, 2015
K151759 · Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
- The Binding SiteMar 18, 2014
K140105 · HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII