Definition: Intended For The In-vitro Quantification Of IgM Kappa Concentration In Human Serum. The Result Is To Be Used With Previously Diagnosed Igm Waldenstoms Macrolobulinaemia, In Conjunction With Other Clinical And Laboratory Findings.
| Device Type ID | 3099 |
| Device Name | Immunoglobulin M Kappa Heavy And Light Chain Combined |
| Physical State | Kit Is Composed Of Polyclonal Monospecific Sheep Anti-IgM Kappa Antibody, IgM Kappa Calibrator, 2 IgM Kappa Controls, And IgM Kappa Supplementary Reagent |
| Technical Method | Nephelometric Immunoassay Method |
| Target Area | Human Peripheral Blood, Serum |
| Regulation Description | Immunoglobulins A, G, M, D, And E Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5510 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3099 |
| Device | Immunoglobulin M Kappa Heavy And Light Chain Combined |
| Product Code | PDE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Immunoglobulins A, G, M, D, And E Immunological Test System. |
| CFR Regulation Number | 866.5510 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
THE BINDING SITE GROUP LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |