QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
Device Facts
| Record ID | K871940 |
|---|---|
| Device Name | QM300 IGA, ANTIGEN, ANTISERUM, CONTROL |
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc. |
| Product Code | CZP · Immunology |
| Decision Date | Jun 12, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
Regulatory Classification
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.
