OPX · Class II · 21 CFR 866.5510

FDA Product Code OPX: Immunoglobulin A Kappa Heavy & Light Chain Combined

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.

Leading manufacturers include The Binding Site Group , Ltd. and The Binding Site.

3
Total
3
Cleared
92d
Avg days
2014
Since

FDA 510(k) Cleared Immunoglobulin A Kappa Heavy & Light Chain Combined Devices (Product Code OPX)

3 devices
1–3 of 3
Cleared Jun 16, 2016
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
K160819
The Binding Site Group , Ltd.
Immunology · 84d
Cleared Nov 06, 2015
Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
K151759
The Binding Site Group , Ltd.
Immunology · 130d
Cleared Mar 18, 2014
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
K140105
The Binding Site
Immunology · 62d

About Product Code OPX - Regulatory Context