SPIFE IFE CALIBRATOR AND CONTROL KIT
Device Facts
| Record ID | K010617 |
|---|---|
| Device Name | SPIFE IFE CALIBRATOR AND CONTROL KIT |
| Applicant | Helena Laboratories |
| Product Code | DEW · Immunology |
| Decision Date | Mar 15, 2001 |
| 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.
