PDE · Immunoglobulin M Kappa Heavy And Light Chain Combined
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | PDE |
|---|---|
| Device Name | Immunoglobulin M Kappa Heavy And Light Chain Combined |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit | The Binding Site Group , Ltd. | Dec 18, 2015 | SESE |
| K140686 | HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | Aug 6, 2014 | SESE |
Top Applicants
- The Binding Site Group , Ltd. — 2 clearances
