COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)
Device Facts
| Record ID | K893419 |
|---|---|
| Device Name | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) |
| Applicant | Coulter Immunology |
| Product Code | DEW · Immunology |
| Decision Date | Aug 3, 1989 |
| 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.
