Definition: Intended For The In-vitro Quantification Of IgM Lambda 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 | 3100 |
| Device Name | Immunoglobulin M Lambda Heavy And Light Chain Combined |
| Physical State | Kit Is Composed Of Polyclonal Monospecific Sheep Anti-IgM Lambda Antibody, IgM Lambda Calibrator, 2 IgM Lambda Controls, And IgM Lambda Supplementary Reagent |
| Technical Method | Nephelometric Immunoassay Method |
| Target Area | Peripheral Human 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 | |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3100 |
| Device | Immunoglobulin M Lambda Heavy And Light Chain Combined |
| Product Code | |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Immunoglobulins A, G, M, D, And E Immunological Test System. |
| CFR Regulation Number | 866.5510 [🔎] |
| Device Problems | |
|---|---|
Wireless Communication Problem | 4 |
Transmitter | 1 |
| Total Device Problems | 5 |