Device |
immunoglobulin a kappa heavy & light chain combined |
Regulation Description |
Immunoglobulins A, G, M, D, and E immunological test system. |
Definition |
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. |
Physical State |
Kit is composed of polyclonal monospecific sheep anti-IgA Kappa antibody, IgA Kappa calibrator, 2 IgA Kappa Controls, and IgA Kappa Supplementary Reagent |
Technical Method |
Nephelometric method |
Target Area |
Blood serum |
Regulation Medical Specialty |
Immunology |
Review Panel |
Immunology |
Product Code | OPX |
Premarket Review |
Division of Immunology and Hematology Devices
(DIHD)
Division of Immunology and Hematology Devices
(DIHD)
|
Submission Type |
510(k)
|
Regulation Number |
866.5510
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|